A Comparative Study of Two Dry Needling Interventions for Plantar Heel Pain

• ClinicalTrials.gov Identifier: NCT03236779
• Recruitment Status: Completed
• First Posted: August 2, 2017
• Results First Posted: January 26, 2021
• Last Update Posted: January 26, 2021
• Sponsor: Universidad de Zaragoza
• Collaborators: Universidad San Jorge; Ministry of Health, Kuwait
• Information provided by (Responsible Party): ZAID AL BOLOUSHI, Universidad de Zaragoza

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Treatment
• Conditions: Plantar Fascitis; Myofacial Pain Syndromes; Trigger Point Pain, Myofascial
• Intervention: Other: dry needling
• Enrollment: 102

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Dry Needling (DN) Arm	Percutaneous Needle Electrolysis (PNE) Arm
Arm/Group Description	Once the clinician locates the MTrP, he will insert the needle over it and he will do a quick entry of the needle. The chosen technique to manipulate the needle will be Hong technique, which consist of quick entry and exit of the needle (fast in/fast out) to get local twitch response (LTR), it will be repeated 5 times with a rhythmic movement of 1Hz/sec. LTRs will be counted and registered. dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied.	The electrotherapy equipment used (Enraf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3, 1.5 mA for 5 seconds conveyed to the muscle will be applied. It will be done exactly the same way as in the DN group with the only difference that the needle will be transmitting the electrical current. dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied.
Period Title: Overall Study
Started	51	51
Completed	38	30
Not Completed	13	21
Reason Not Completed
Lost to Follow-up	13	21

Baseline Characteristics

Arm/Group Title		Dry Needling (DN) Arm	Percutaneous Needle Electrolysis (PNE) Arm	Total
Arm/Group Description		Once the clinician locates the MTrP, he will insert the needle over it and he will do a quick entry of the needle. The chosen technique to manipulate the needle will be Hong technique, which consist of quick entry and exit of the needle (fast in/fast out) to get local twitch response (LTR), it will be repeated 5 times with a rhythmic movement of 1Hz/sec. LTRs will be counted and registered. dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied.	The electrotherapy equipment used (Enraf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3, 1.5 mA for 5 seconds conveyed to the muscle will be applied. It will be done exactly the same way as in the DN group with the only difference that the needle will be transmitting the electrical current. dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied.	Total of all reporting groups
Overall Number of Baseline Participants		51	51	102
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	51 participants	51 participants	102 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	51 100.0%	51 100.0%	102 100.0%
	>=65 years	0 0.0%	0 0.0%	0 0.0%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	51 participants	51 participants	102 participants
		49.5 (8.9)	48.1 (8.8)	48.8 (8.8)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	51 participants	51 participants	102 participants
	Female	36 70.6%	36 70.6%	72 70.6%
	Male	15 29.4%	15 29.4%	30 29.4%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	51 participants	51 participants	102 participants
	Hispanic or Latino	0 0.0%	0 0.0%	0 0.0%
	Not Hispanic or Latino	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	51 100.0%	51 100.0%	102 100.0%
Region of Enrollment; Measure Type: Count of Participants; Unit of measure: Participants
Kuwait	Number Analyzed	51 participants	51 participants	102 participants
		51 100.0%	51 100.0%	102 100.0%

Outcome Measures

1. Primary Outcome

Title	Foot Health Status Questioner (FHSQ) PAIN
Description	Participants will complete the FHSQ at baseline and at 4, 8, 12, 26, and 52 weeks post-treatment. The FHSQ consists of 13 questions reflecting fourfoot health-related domains: pain (4 questions), function (4 questions), footwear (3 questions), and general foot health (2 questions). Individual item scores will then be re-coded, tabulated, and finally transformed to a scale ranging from 0 to 100 for each of the four domains. Greater scores reflect better foot health and quality of life. The FHSQ has been validated and has been used in similar trials that have evaluated the effectiveness of different interventions for plantar heel pain
Time Frame	Baseline, 4 weeks, 8 weeks, 12 weeks, 26 weeks, 52 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dry Needling (DN) Arm	Percutaneous Needle Electrolysis (PNE) Arm
Arm/Group Description:	Once the clinician locates the MTrP, he will insert the needle over it and he will do a quick entry of the needle. The chosen technique to manipulate the needle will be Hong technique, which consist of quick entry and exit of the needle (fast in/fast out) to get local twitch response (LTR), it will be repeated 5 times with a rhythmic movement of 1Hz/sec. LTRs will be counted and registered. dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied.	The electrotherapy equipment used (Enraf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3, 1.5 mA for 5 seconds conveyed to the muscle will be applied. It will be done exactly the same way as in the DN group with the only difference that the needle will be transmitting the electrical current. dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied.
Overall Number of Participants Analyzed	51	51
Mean (Standard Deviation); Unit of Measure: score on a scale
baseline	38.8 (18.8)	40.4 (21.9)
4 weeks	73.4 (27.7)	71.9 (25.7)
8 weeks	70.1 (28.4)	67.4 (26.8)
12 weeks	66.8 (24.8)	63.6 (26.8)
26 weeks	68.8 (25.3)	67.1 (27.1)
52 weeks	68.4 (25.1)	73.1 (29.0)

2. Primary Outcome

Title	Foot Health Status Questioner (FHSQ) PAIN
Description	Participants will complete the FHSQ at baseline and at 4, 8, 12, 26, and 52 weeks post-treatment. The FHSQ consists of 13 questions reflecting fourfoot health-related domains: pain (4 questions), function (4 questions), footwear (3 questions), and general foot health (2 questions). Individual item scores will then be re-coded, tabulated, and finally transformed to a scale ranging from 0 to 100 for each of the four domains. Greater scores reflect better foot health and quality of life. The FHSQ has been validated and has been used in similar trials that have evaluated the effectiveness of different interventions for plantar heel pain
Time Frame	Baseline, 4 weeks, 8 weeks, 12 weeks, 26 weeks, 52 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dry Needling (DN) Arm	Percutaneous Needle Electrolysis (PNE) Arm
Arm/Group Description:	Once the clinician locates the MTrP, he will insert the needle over it and he will do a quick entry of the needle. The chosen technique to manipulate the needle will be Hong technique, which consist of quick entry and exit of the needle (fast in/fast out) to get local twitch response (LTR), it will be repeated 5 times with a rhythmic movement of 1Hz/sec. LTRs will be counted and registered. dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied.	The electrotherapy equipment used (Enraf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3, 1.5 mA for 5 seconds conveyed to the muscle will be applied. It will be done exactly the same way as in the DN group with the only difference that the needle will be transmitting the electrical current. dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied.
Overall Number of Participants Analyzed	51	51
Mean (Standard Deviation); Unit of Measure: score on a scale
baseline	38.8 (18.8)	40.4 (21.9)
4 weeks	73.4 (27.7)	71.9 (25.7)
8 weeks	70.1 (28.4)	67.4 (26.8)
12 weeks	66.8 (24.8)	63.6 (26.8)
26 weeks	68.8 (25.3)	67.1 (27.1)
52 weeks	68.4 (25.1)	73.1 (29.0)

3. Secondary Outcome

Title	VAS Maximum
Description	Participants will complete the visual analogue scale (VAS) before each treatment session, considering the level of pain they have just before start the treatment session and the highest level of pain they have had during the last 48 hours. The exact words of the questions will be: 1) what is the level of pain, as average, you have feel during last 48 hours?; and 2) what is the maximum level of pain you have feel during last 48 hours? Participants will be explained that a score of 0 indicates the absence of pain whereas a score of 10 represents the maximum tolerable pain. The VAS is widely used and is valid and reliable
Time Frame	1st session (baseline), 2nd session (week 2), 3rd session (week 3), 4th session (week 4)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	VAS DN	VAS PNE
Arm/Group Description:	the average and maximum level of pain over the past 48 hours using the visual analogue scale (VAS). Participants were explained that a score of 0 indicated the absence of pain whereas a score of 10 represented the maximum tolerable pain	the average and maximum level of pain over the past 48 hours using the visual analogue scale (VAS). Participants were explained that a score of 0 indicated the absence of pain whereas a score of 10 represented the maximum tolerable pain
Overall Number of Participants Analyzed	51	51
Mean (Standard Deviation); Unit of Measure: units on a scale
baseline 1st session	7.6 (2.0)	7.5 (2.3)
2nd session	6.2 (2.3)	5.5 (2.9)
3rd session	5.4 (2.6)	5.3 (3.1)
4th session	4.9 (2.9)	4.5 (3.0)

4. Secondary Outcome

Title	The Quality of Life (QoL) Will be Assessed With the EuroQoL-5 Dimensions (EQ-5D)
Description	The EQ-5D-5L self-report questionnaire is a descriptive system with five questions, each representing one dimension of health-related QoL, that is, mobility, self-care, daily activities, pain/discomfort and depression/anxiety. Each dimension can be rated on five levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Scoring is based on a 0 to 100% scale, where 100% represent the best QoL.
Time Frame	Baseline, 4 weeks, 8 weeks, 12 weeks, 26 weeks, 52 weeks"

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dry Needling (DN) Arm	Percutaneous Needle Electrolysis (PNE) Arm
Arm/Group Description:	Once the clinician locates the MTrP, he will insert the needle over it and he will do a quick entry of the needle. The chosen technique to manipulate the needle will be Hong technique, which consist of quick entry and exit of the needle (fast in/fast out) to get local twitch response (LTR), it will be repeated 5 times with a rhythmic movement of 1Hz/sec. LTRs will be counted and registered. dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied.	The electrotherapy equipment used (Enraf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3, 1.5 mA for 5 seconds conveyed to the muscle will be applied. It will be done exactly the same way as in the DN group with the only difference that the needle will be transmitting the electrical current. dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied.
Overall Number of Participants Analyzed	51	51
Mean (Standard Deviation); Unit of Measure: units on a scale
baseline	0.63 (0.23)	0.67 (0.22)
4 weeks	0.78 (0.22)	0.76 (0.24)
8 weeks	0.72 (0.23)	0.74 (0.23)
12 weeks	0.64 (0.30)	0.70 (0.27)
26 weeks	0.65 (0.29)	0.73 (0.27)
52 weeks	0.66 (0.27)	0.77 (0.25)

Adverse Events

Time Frame	1 year follow up
Adverse Event Reporting Description	Unable to tolerate pain of the treatment
Arm/Group Title	Dry Needling		Percutaneous Needle Electrolysis
Arm/Group Description	Once the clinician located the MTrP, the needle was inserted over the same and a rapid needle entry was performed. The chosen technique for manipulating the needle was the technique described by Hong, which consists of a rapid needle entry and exit (fast in/fast out), in order to obtain a local twitch response, lasting 5 seconds employing a rhythmic movement at approximately 1Hz/sec (5 entries).		The electrotherapy equipment used (Physio Invasiva, PRIM Fisioterapia, Spain) produced a continuous galvanic current through the cathode while the patient held a hand-held anode.18 Once the needle reached the relevant treatment area, this was needled in exactly the same manner as in the dry needling group, with the only difference being that the needle was transmitting an electrical current with an intensity of 1.5 mA (intensity was adapted to patient´s characteristics according to their pain tolerance).
All-Cause Mortality
	Dry Needling		Percutaneous Needle Electrolysis
	Affected / at Risk (%)		Affected / at Risk (%)
Total	0/51 (0.00%)		0/51 (0.00%)
Serious Adverse Events
	Dry Needling		Percutaneous Needle Electrolysis
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/51 (0.00%)		0/51 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Dry Needling		Percutaneous Needle Electrolysis
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/51 (17.65%)		14/51 (27.45%)
Musculoskeletal and connective tissue disorders
unable to tolerate pain † 1 [1]	9/51 (17.65%)	9	14/51 (27.45%)	14
1 Term from vocabulary, drop out; † Indicates events were collected by systematic assessment; [1] Unable to tolerate pain of the treatment

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. Pablo Herrero Gallego. PT, PhD.
• Organization: Head of iPhysio Research Group. Editor-in-Chief Journal of Invasive Techniques in Physical Therapy
• Phone: (+34) 646168248
• EMail: pherrero@usj.es

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

Al-Boloushi Z, Gómez-Trullén EM, Arian M, Fernández D, Herrero P, Bellosta-López P. Comparing two dry needling interventions for plantar heel pain: a randomised controlled trial. BMJ Open. 2020 Aug 20;10(8):e038033. doi: 10.1136/bmjopen-2020-038033.

Al-Boloushi Z, Gómez-Trullén EM, Bellosta-López P, López-Royo MP, Fernández D, Herrero P. Comparing two dry needling interventions for plantar heel pain: a protocol for a randomized controlled trial. J Orthop Surg Res. 2019 Jan 25;14(1):31. doi: 10.1186/s13018-019-1066-4.

• Responsible Party: ZAID AL BOLOUSHI, Universidad de Zaragoza
• ClinicalTrials.gov Identifier: NCT03236779
• Other Study ID Numbers: ALBOLOUSHI
• First Submitted: July 25, 2017
• First Posted: August 2, 2017
• Results First Submitted: July 30, 2020
• Results First Posted: January 26, 2021
• Last Update Posted: January 26, 2021