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

NCT03236779 | Completed Results DMC

• 1 other identifier: ALBOLOUSHI
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline, 4 weeks, 8 weeks, 12 weeks, 26 weeks, 52 weeks

Secondary Outcomes (2)

• VAS Maximum

  1st session (baseline), 2nd session (week 2), 3rd session (week 3), 4th session (week 4)

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

  Baseline, 4 weeks, 8 weeks, 12 weeks, 26 weeks, 52 weeks"

Study Arms (2)

Dry needling (DN) arm

EXPERIMENTAL

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.

Other: dry needling

Percutaneous needle electrolysis (PNE) arm

ACTIVE COMPARATOR

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.

Other: dry needling

Interventions

dry needling OTHER

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.

Also known as: Percutaneous needle electrolysis

Dry needling (DN) arm; Percutaneous needle electrolysis (PNE) arm

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Universidad de Zaragoza: lead
• Universidad San Jorge: collaborator
• Ministry of Health, Kuwait: collaborator

Study Sites (1)

Physical Medicine and rehabilitation Kuwait

Kuwait City, Kuwait

Location

Related Publications (3)

• 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.

  PMID: 33673068 DERIVED

• 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.

  PMID: 32819949 DERIVED

• 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.

  PMID: 30683124 DERIVED

MeSH Terms

Conditions

Facial Neuralgia; Myofascial Pain Syndromes

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Results Point of Contact

• Title: Dr. Pablo Herrero Gallego. PT, PhD.
• Organization: Head of iPhysio Research Group. Editor-in-Chief Journal of Invasive Techniques in Physical Therapy

pherrero@usj.es

(+34) 646168248

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Model Details: 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

Study Record Dates

• First Submitted: July 25, 2017
• First Posted: August 2, 2017
• Study Start: January 14, 2018
• Primary Completion: October 10, 2019
• Study Completion: December 20, 2019
• Last Updated: January 26, 2021
• Results First Posted: January 26, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

KU (1)