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

Plantar Fascitis Clinical Trial

Official title:

A Comparative Study of Two Dry Needling Interventions for Plantar Heel Pain: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03236779
• Other study ID #: ALBOLOUSHI
• Status: Completed
• Phase: N/A
• Start date: January 14, 2018
• Est. completion date: December 20, 2019

Study information

• Verified date: January 2021
• Source: Universidad de Zaragoza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: December 20, 2019
• Est. primary completion date: October 10, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Facial Neuralgia
• Facial Pain
• Fasciitis
• Fasciitis, Plantar
• Myofacial Pain Syndromes
• Myofascial Pain Syndromes
• Plantar Fascitis
• 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.

Locations

Country	Name	City	State
Kuwait	Physical Medicine and rehabilitation Kuwait	Kuwait

Sponsors (3)

Lead Sponsor	Collaborator
Universidad de Zaragoza	Ministry of Health, Kuwait, Universidad San Jorge

Country where clinical trial is conducted

Kuwait, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	1st session (baseline), 2nd session (week 2), 3rd session (week 3), 4th session (week 4)
Secondary	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.	Baseline, 4 weeks, 8 weeks, 12 weeks, 26 weeks, 52 weeks"