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

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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:
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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dry Needling (DN) Arm Percutaneous Needle Electrolysis (PNE) Arm
Hide 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
Arm/Group Title Dry Needling (DN) Arm Percutaneous Needle Electrolysis (PNE) Arm Total
Hide 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
Hide 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%
1.Primary Outcome
Title Foot Health Status Questioner (FHSQ) PAIN
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dry Needling (DN) Arm Percutaneous Needle Electrolysis (PNE) Arm
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dry Needling (DN) Arm Percutaneous Needle Electrolysis (PNE) Arm
Hide 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
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VAS DN VAS PNE
Hide 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)
Hide 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"
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dry Needling (DN) Arm Percutaneous Needle Electrolysis (PNE) Arm
Hide 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)
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
Hide 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%)    
Hide 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%)    
Hide 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
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
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
Layout table for additonal information
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