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

Primary Purpose

Plantar Fascitis, Myofacial Pain Syndromes, Trigger Point Pain, Myofascial

Status
Completed
Phase
Not Applicable
Locations
Kuwait
Study Type
Interventional
Intervention
dry needling
Sponsored by
Universidad de Zaragoza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plantar Fascitis

Eligibility Criteria

21 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Clinical diagnosis of PHP in accordance with the Clinical Guidelines linked to the International Classification of Function, Disability, and Health from the Orthopedic Section of the American Physical Therapy Association
  • Age greater than 21 years according to the Kuwaiti law.
  • History of plantar heel pain for greater than one month.
  • Walking 50 meters without any support
  • Having MTPs on initial physical examination on plantar and calf muscles
  • Accepting to be treated by a male physiotherapist.
  • Capacity to understand the study and the informed consent, as well as having signed the document.

Exclusion Criteria:

  • - Needle phobia
  • Allergy from needles or hypersensitivity to metals
  • Presence of coagulopathy or use of anticoagulants
  • Presence of peripheral arterial vascular disease
  • Pregnancy
  • Dermatological disease with the dry needling area
  • The presence of a chronic medical condition that might preclude participation in the study such as malignancy, systemic inflammatory disorders (e.g. psoriatic arthritis, ankylosing spondylitis, septic arthritis), neurological diseases, polyneuropathy, mononeuropathy.
  • Treatment of plantar heel pain with needling or acupuncture during last 4 weeks.
  • A history of injection therapy in the heel in the previous three months.
  • Previous history of foot surgery or fracture.

Sites / Locations

  • Physical Medicine and rehabilitation Kuwait

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dry needling (DN) arm

Percutaneous needle electrolysis (PNE) arm

Arm 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.

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.

Outcomes

Primary Outcome Measures

Foot Health Status Questioner (FHSQ) PAIN
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

Secondary Outcome Measures

VAS Maximum
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
The Quality of Life (QoL) Will be Assessed With the EuroQoL-5 Dimensions (EQ-5D)
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.

Full Information

First Posted
July 25, 2017
Last Updated
January 23, 2021
Sponsor
Universidad de Zaragoza
Collaborators
Universidad San Jorge, Ministry of Health, Kuwait
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1. Study Identification

Unique Protocol Identification Number
NCT03236779
Brief Title
A Comparative Study of Two Dry Needling Interventions for Plantar Heel Pain
Official Title
A Comparative Study of Two Dry Needling Interventions for Plantar Heel Pain: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 14, 2018 (Actual)
Primary Completion Date
October 10, 2019 (Actual)
Study Completion Date
December 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Zaragoza
Collaborators
Universidad San Jorge, Ministry of Health, Kuwait

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a clinical trial that will be done in the state of Kuwait, at the physical rehabilitation medicine hospital. the participants will be recruited from all over Kuwait, there is a clinical registry upon the ethical committee in Kuwait assigned by the ministry of health.
Detailed Description
Physical therapy approaches continue evolving. During the last years, minimally invasive techniques such as percutaneous needle electrolysis (PNE) was being developed, obtaining promising results for tendon pathology. PNE technique is a minimally invasive treatment that consists of an application of a galvanic electrolytic current that causes a controlled local inflammatory process in the target tissue. This allows for phagocytosis and the subsequent regeneration of the affected tissue. Nowadays, PNE is being used in clinical practice to manage MTrP, but there are no studies supporting that they have an additional beneficial effect over DN. From a biological point of view, it seems reasonable to ascertain that a patient will obtain benefits thanks to the mechanical effects provided by the needle and that patients may benefit more if the electrolysis effect is added to the mechanical stimuli provided by the needle. Therefore, the aim of this randomized controlled study is to compare the effectiveness of DN versus PNE for the level of pain in patients suffering from PHP.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plantar Fascitis, Myofacial Pain Syndromes, Trigger Point Pain, Myofascial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study is a prospective, two parallel-groups (participant) randomized controlled trial with blinded outcome assessment at baseline, and at 4, 8, 12, 26 and 52 weeks. The study flow chart shown in Figure 1 conforms to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines for nonpharmacological studies
Masking
ParticipantOutcomes Assessor
Masking Description
Participants who fulfill the inclusion criteria will receive the standardized oral and written information, and, once they consent to participate in the trial, will be randomized in a block system by blocks of 10 patients. Allocation to the groups will be achieved using a computer program (Randomizer, https://www.randomizer.org/) generated a random patient file numbers sequence by a third person not involved in the study from the file section in Kuwait. This person will be responsible for guarding the envelope with the information of the randomization. The envelopes will be closed until the moment of the intervention to maintain the blinding. This professional also will ask the patients for informed consent. The consent form is recruited upon the ethical medical committee at the ministry of health in the state of Kuwait.
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dry needling (DN) arm
Arm Type
Experimental
Arm 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.
Arm Title
Percutaneous needle electrolysis (PNE) arm
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
dry needling
Other Intervention Name(s)
Percutaneous needle electrolysis
Intervention Description
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.
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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)
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"

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of PHP in accordance with the Clinical Guidelines linked to the International Classification of Function, Disability, and Health from the Orthopedic Section of the American Physical Therapy Association Age greater than 21 years according to the Kuwaiti law. History of plantar heel pain for greater than one month. Walking 50 meters without any support Having MTPs on initial physical examination on plantar and calf muscles Accepting to be treated by a male physiotherapist. Capacity to understand the study and the informed consent, as well as having signed the document. Exclusion Criteria: - Needle phobia Allergy from needles or hypersensitivity to metals Presence of coagulopathy or use of anticoagulants Presence of peripheral arterial vascular disease Pregnancy Dermatological disease with the dry needling area The presence of a chronic medical condition that might preclude participation in the study such as malignancy, systemic inflammatory disorders (e.g. psoriatic arthritis, ankylosing spondylitis, septic arthritis), neurological diseases, polyneuropathy, mononeuropathy. Treatment of plantar heel pain with needling or acupuncture during last 4 weeks. A history of injection therapy in the heel in the previous three months. Previous history of foot surgery or fracture.
Facility Information:
Facility Name
Physical Medicine and rehabilitation Kuwait
City
Kuwait
Country
Kuwait

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
ACCORDING TO THE LAW AND REGULATIONS FROM THE ETHICAL COMMITTEE IN KUWAIT. I CAN'T SHARE THE NAME OF THE PATIENTS, THEIR CONTACT OR ID. OTHER DATA WHICH ARE RELATED TO THE STUDY I CAN SHARE.
Citations:
PubMed Identifier
33673068
Citation
Fernandez D, Al-Boloushi Z, Bellosta-Lopez P, Herrero P, Gomez M, Calvo S. Cost-Effectiveness of Two Dry Needling Interventions for Plantar Heel Pain: A Secondary Analysis of an RCT. Int J Environ Res Public Health. 2021 Feb 12;18(4):1777. doi: 10.3390/ijerph18041777.
Results Reference
derived
PubMed Identifier
32819949
Citation
Al-Boloushi Z, Gomez-Trullen EM, Arian M, Fernandez D, Herrero P, Bellosta-Lopez 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.
Results Reference
derived
PubMed Identifier
30683124
Citation
Al-Boloushi Z, Gomez-Trullen EM, Bellosta-Lopez P, Lopez-Royo MP, Fernandez 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.
Results Reference
derived

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

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