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

Tracking Information

• First Submitted Date: July 25, 2017
• First Posted Date: August 2, 2017
• Results First Submitted Date: July 30, 2020
• Results First Posted Date: January 26, 2021
• Last Update Posted Date: January 26, 2021
• Actual Study Start Date: January 14, 2018
• Actual Primary Completion Date: October 10, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 23, 2021)

Foot Health Status Questioner (FHSQ) PAIN [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 26 weeks, 52 weeks ]

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

• Original Primary Outcome Measures (submitted: August 1, 2017): Foot Health status questioner (FHSQ) [ Time Frame: 10 Minutes ]

Current Secondary Outcome Measures (submitted: January 23, 2021)

• VAS Maximum [ Time Frame: 1st session (baseline), 2nd session (week 2), 3rd session (week 3), 4th session (week 4) ]
  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) [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 26 weeks, 52 weeks" ]
  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.

Original Secondary Outcome Measures (submitted: August 1, 2017)

• VAS [ Time Frame: 5 Minute ]
  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 [ Time Frame: 5 minute ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Double (Participant, Outcomes 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.

Primary Purpose: Treatment

Condition

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

Intervention

Other: 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.

Other Name: Percutaneous needle electrolysis

Study Arms

• Experimental: Dry needling (DN) arm
  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.
  Intervention: Other: dry needling
• Active Comparator: Percutaneous needle electrolysis (PNE) arm
  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: Other: dry needling

Publications *

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 9, 2019): 102
• Original Estimated Enrollment (submitted: August 1, 2017): 94
• Actual Study Completion Date: December 20, 2019
• Actual Primary Completion Date: October 10, 2019 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Kuwait

Administrative Information

• NCT Number: NCT03236779
• Other Study ID Numbers: ALBOLOUSHI
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No
• 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.

• Responsible Party: ZAID AL BOLOUSHI, Universidad de Zaragoza
• Study Sponsor: Universidad de Zaragoza

Collaborators

• Universidad San Jorge
• Ministry of Health, Kuwait

• Investigators: Not Provided
• PRS Account: Universidad de Zaragoza
• Verification Date: January 2021