The Mechanisms of Manual Therapy in the Treatment of Low Back Pain

• ClinicalTrials.gov Identifier: NCT01168999
• Recruitment Status: Completed
• First Posted: July 23, 2010
• Results First Posted: December 23, 2013
• Last Update Posted: October 28, 2015
• Sponsor: University of Florida
• Information provided by (Responsible Party): University of Florida

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: Low Back Pain
• Interventions: Other: spinal manipulation; Other: sham spinal manipulation; Other: Enhanced sham spinal manipulation
• Enrollment: 110

Participant Flow

Recruitment Details	The study was undertaken in a lab on the University of Florida. Participants were recruited through written and electronic advertisement approved by the University of Florida Institutional Review Board. The first participant was enrolled in the study in November of 2009 and the final participant completed the study in January of 2013.
Pre-assignment Details

Arm/Group Title	Spinal Manipulative Therapy	Sham Spinal Manipulative Therapy	Enhanced Sham Spinal Manipulative Therapy	Natural History
Arm/Group Description	Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks	Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.	Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.	These participants sat quietly for 5 minutes during the initial and final testing sessions.
Period Title: Overall Study
Started	28	27	27	28
Completed	26	26	27	28
Not Completed	2	1	0	0
Reason Not Completed
Lost to Follow-up	2	1	0	0

Baseline Characteristics

Arm/Group Title		Spinal Manipulative Therapy	Sham Spinal Manipulative Therapy	Enhanced Sham Spinal Manipulative Therapy	Natural History	Total
Arm/Group Description		Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks	Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.	Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.	These participants sat quietly for 5 minutes during the initial and final testing sessions.	Total of all reporting groups
Overall Number of Baseline Participants		28	27	27	28	110
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	28 participants	27 participants	27 participants	28 participants	110 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	28 100.0%	27 100.0%	27 100.0%	28 100.0%	110 100.0%
	>=65 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	28 participants	27 participants	27 participants	28 participants	110 participants
		32.07 (10.98)	33.22 (13.29)	31.56 (11.85)	29.85 (12.09)	31.68 (11.85)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	28 participants	27 participants	27 participants	28 participants	110 participants
	Female	21 75.0%	17 63.0%	20 74.1%	19 67.9%	77 70.0%
	Male	7 25.0%	10 37.0%	7 25.9%	9 32.1%	33 30.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	28 participants	27 participants	27 participants	28 participants	110 participants
		28	27	27	28	110

Outcome Measures

1. Primary Outcome

Title	Believability of Placebo
Description	Assess whether or not participants receiving the placebo are blinded to the fact they are receiving the placebo as indicated by the percentage of participants in each arm of the study believing they received SMT
Time Frame	baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Spinal Manipulative Therapy	Sham Spinal Manipulative Therapy	Enhanced Sham Spinal Manipulative Therapy	Natural History
Arm/Group Description:	Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks	Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.	Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.	These participants sat quietly for 5 minutes during the initial and final testing sessions.
Overall Number of Participants Analyzed	28	27	27	0
Measure Type: Number; Unit of Measure: percentage of participants
	67	37	78

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Spinal Manipulative Therapy, Sham Spinal Manipulative Therapy, Enhanced Sham Spinal Manipulative Therapy
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.01
	Comments	[Not Specified]
	Method	Chi-squared
	Comments	[Not Specified]

2. Primary Outcome

Title	Expectation for Treatment Effectiveness
Description	how helpful participants expect the assigned intervention will be in decreasing their low back pain
Time Frame	baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Spinal Manipulative Therapy	Sham Spinal Manipulative Therapy	Enhanced Sham Spinal Manipulative Therapy	Natural History
Arm/Group Description:	Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks	Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.	Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.	These participants sat quietly for 5 minutes during the initial and final testing sessions.
Overall Number of Participants Analyzed	28	27	27	28
Measure Type: Number; Unit of Measure: percent expecting less pain
	54	26	59	11

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Spinal Manipulative Therapy, Sham Spinal Manipulative Therapy, Enhanced Sham Spinal Manipulative Therapy, Natural History
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.01
	Comments	[Not Specified]
	Method	Chi-squared
	Comments	[Not Specified]

3. Primary Outcome

Title	Change From Baseline at 2 Weeks in Clinical Pain as Measured by a Numeric Rating Scale
Description	A 101 point numeric rating scale with 0= no pain at all to 100= worst pain imaginable of low back pain
Time Frame	Change from Baseline at 2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Spinal Manipulative Therapy	Sham Spinal Manipulative Therapy	Enhanced Sham Spinal Manipulative Therapy	Natural History
Arm/Group Description:	Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks	Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.	Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.	These participants sat quietly for 5 minutes during the initial and final testing sessions.
Overall Number of Participants Analyzed	26	26	27	28
Mean (Standard Deviation); Unit of Measure: units on a scale
	11.23 (14.01)	14.03 (17.88)	9.44 (25.90)	8.20 (12.64)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Spinal Manipulative Therapy, Sham Spinal Manipulative Therapy, Enhanced Sham Spinal Manipulative Therapy, Natural History
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	>0.05
	Comments	[Not Specified]
	Method	Repeated Measure ANOVA
	Comments	[Not Specified]

4. Primary Outcome

Title	Change From Baseline at 2 Weeks in Disability as Measured by the Oswestry Disability Index
Description	The Oswestry Disability Index is a 10 item questionnaire measuring low back pain related disability. Individual item scores range from 0 to 5. Scores on all items are summed and multiplied by 2 to provide a percentage ranging between 0 to 100 with higher scores indicating greater low back pain related disability.
Time Frame	Change from Baseline at 2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Spinal Manipulative Therapy	Sham Spinal Manipulative Therapy	Enhanced Sham Spinal Manipulative Therapy	Natural History
Arm/Group Description:	Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks	Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.	Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.	These participants sat quietly for 5 minutes during the initial and final testing sessions.
Overall Number of Participants Analyzed	26	26	27	28
Mean (Standard Deviation); Unit of Measure: units on a scale
	4.46 (8.28)	2.08 (7.36)	2.69 (8.33)	2.54 (8.47)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Spinal Manipulative Therapy, Sham Spinal Manipulative Therapy, Enhanced Sham Spinal Manipulative Therapy, Natural History
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	>0.05
	Comments	[Not Specified]
	Method	Repeated Measure ANOVA
	Comments	[Not Specified]

5. Primary Outcome

Title	Change in Pain Sensitivity From Baseline to Immediately Following the Assigned Intervention as Measured by a Visual Analog Scale
Description	Participants received a standard thermal stimulus to the bottom of their foot prior to and immediately following their assigned intervention. Participants rated their pain in response to this thermal stimulus using a 101 mm visual analog scale with 0 mm indicating "no pain at all" and 100 mm indicating "the worst pain imaginable".
Time Frame	baseline and immediately following their assigned intervention during the initial session

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Spinal Manipulative Therapy	Sham Spinal Manipulative Therapy	Enhanced Sham Spinal Manipulative Therapy	Natural History
Arm/Group Description:	Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks	Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.	Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.	These participants sat quietly for 5 minutes during the initial and final testing sessions.
Overall Number of Participants Analyzed	28	27	27	28
Mean (Standard Deviation); Unit of Measure: units on a scale
	8.14 (20.48)	-3.04 (12.92)	1.22 (16.03)	-2.93 (17.84)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Spinal Manipulative Therapy, Sham Spinal Manipulative Therapy, Enhanced Sham Spinal Manipulative Therapy, Natural History
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.05
	Comments	[Not Specified]
	Method	Repeated Measure ANOVA
	Comments	[Not Specified]

6. Secondary Outcome

Title	Change From Baseline at 2 Weeks in Low Back Flexion Range of Motion
Description	Low back flexion range of motion was measured in degrees using a gravity inclinometer
Time Frame	Change from Baseline at 2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Spinal Manipulative Therapy	Sham Spinal Manipulative Therapy	Enhanced Sham Spinal Manipulative Therapy	Natural History
Arm/Group Description:	Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks	Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.	Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.	These participants sat quietly for 5 minutes during the initial and final testing sessions.
Overall Number of Participants Analyzed	26	26	27	28
Mean (Standard Deviation); Unit of Measure: degrees
	1.58 (8.65)	2.67 (13.91)	-0.33 (9.55)	-0.54 (9.25)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Spinal Manipulative Therapy, Sham Spinal Manipulative Therapy, Enhanced Sham Spinal Manipulative Therapy, Natural History
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	>0.05
	Comments	[Not Specified]
	Method	Repeated Measure ANOVA
	Comments	[Not Specified]

7. Secondary Outcome

Title	Change From Baseline at 2 Weeks in Low Back Extension Range of Motion
Description	Low back extension range of motion was measured in degrees using a gravity inclinometer
Time Frame	Change from Baseline at 2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Spinal Manipulative Therapy	Sham Spinal Manipulative Therapy	Enhanced Sham Spinal Manipulative Therapy	Natural History
Arm/Group Description:	Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks	Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.	Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.	These participants sat quietly for 5 minutes during the initial and final testing sessions.
Overall Number of Participants Analyzed	26	26	27	28
Mean (Standard Deviation); Unit of Measure: degrees
	-1.50 (9.58)	-0.07 (11.26)	1.26 (4.95)	-0.21 (7.82)

8. Secondary Outcome

Title	Change From Baseline at 2 Weeks in Low Back Right Sidebending Range of Motion
Description	Low back right sidebending range of motion was measured in degrees using a gravity inclinometer
Time Frame	Change from Baseline at 2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Spinal Manipulative Therapy	Sham Spinal Manipulative Therapy	Enhanced Sham Spinal Manipulative Therapy	Natural History
Arm/Group Description:	Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks	Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.	Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.	These participants sat quietly for 5 minutes during the initial and final testing sessions.
Overall Number of Participants Analyzed	26	26	27	28
Mean (Standard Deviation); Unit of Measure: degrees
	0.92 (8.68)	-0.19 (1.24)	0.63 (7.53)	0.50 (9.50)

9. Secondary Outcome

Title	Change From Baseline at 2 Weeks in Low Back Left Sidebending Range of Motion
Description	Low back left sidebending range of motion was measured in degrees using a gravity inclinometer
Time Frame	Change from Baseline at 2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Spinal Manipulative Therapy	Sham Spinal Manipulative Therapy	Enhanced Sham Spinal Manipulative Therapy	Natural History
Arm/Group Description:	Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks	Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.	Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.	These participants sat quietly for 5 minutes during the initial and final testing sessions.
Overall Number of Participants Analyzed	26	26	27	28
Mean (Standard Deviation); Unit of Measure: degrees
	2.15 (8.04)	-0.15 (6.37)	1 (6.66)	-1.36 (6.41)

Adverse Events

Time Frame	The study was conducted from November of 2009 until January of 2013. The occurrence of adverse events was monitored during the length of the study.
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Spinal Manipulative Therapy	Sham Spinal Manipulative Therapy	Enhanced Sham Spinal Manipulative Therapy	Natural History
Arm/Group Description	Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks	Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.	Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.	These participants sat quietly for 5 minutes during the initial and final testing sessions.
All-Cause Mortality
	Spinal Manipulative Therapy	Sham Spinal Manipulative Therapy	Enhanced Sham Spinal Manipulative Therapy	Natural History
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--	--/--	--/--
Serious Adverse Events
	Spinal Manipulative Therapy	Sham Spinal Manipulative Therapy	Enhanced Sham Spinal Manipulative Therapy	Natural History
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/28 (0.00%)	0/27 (0.00%)	0/27 (0.00%)	0/28 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Spinal Manipulative Therapy	Sham Spinal Manipulative Therapy	Enhanced Sham Spinal Manipulative Therapy	Natural History
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/28 (0.00%)	0/27 (0.00%)	0/27 (0.00%)	0/28 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Dr. Joel Bialosky
• Organization: University of Florida
• Phone: 352-273-8636
• EMail: bialosky@phhp.ufl.edu

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bialosky JE, George SZ, Horn ME, Price DD, Staud R, Robinson ME. Spinal manipulative therapy-specific changes in pain sensitivity in individuals with low back pain (NCT01168999). J Pain. 2014 Feb;15(2):136-48. doi: 10.1016/j.jpain.2013.10.005. Epub 2013 Oct 27.

• Responsible Party: University of Florida
• ClinicalTrials.gov Identifier: NCT01168999
• Other Study ID Numbers: 345-2009
• First Submitted: July 22, 2010
• First Posted: July 23, 2010
• Results First Submitted: May 10, 2013
• Results First Posted: December 23, 2013
• Last Update Posted: October 28, 2015