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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

Tracking Information
First Submitted Date  ICMJE July 25, 2017
First Posted Date  ICMJE August 2, 2017
Results First Submitted Date  ICMJE July 30, 2020
Results First Posted Date  ICMJE January 26, 2021
Last Update Posted Date January 26, 2021
Actual Study Start Date  ICMJE January 14, 2018
Actual Primary Completion Date October 10, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (submitted: August 1, 2017)
Foot Health status questioner (FHSQ) [ Time Frame: 10 Minutes ]
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE A Comparative Study of Two Dry Needling Interventions for Plantar Heel Pain
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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  ICMJE
  • Plantar Fascitis
  • Myofacial Pain Syndromes
  • Trigger Point Pain, Myofascial
Intervention  ICMJE 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  ICMJE
  • 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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 9, 2019)
102
Original Estimated Enrollment  ICMJE
 (submitted: August 1, 2017)
94
Actual Study Completion Date  ICMJE December 20, 2019
Actual Primary Completion Date October 10, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Kuwait
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03236779
Other Study ID Numbers  ICMJE 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  ICMJE
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  ICMJE Universidad de Zaragoza
Collaborators  ICMJE
  • Universidad San Jorge
  • Ministry of Health, Kuwait
Investigators  ICMJE Not Provided
PRS Account Universidad de Zaragoza
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP