Clinical trial NCT03236779: 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
Overall status: COMPLETED
Phase: NA
Conditions: Plantar Fascitis
Myofacial Pain Syndromes
Trigger Point Pain, Myofascial
Lead sponsor: Universidad de Zaragoza
Sponsor class: OTHER
Collaborators: name: Universidad San Jorge
name: Ministry of Health, Kuwait
First posted: 2017-08-02
Enrollment: 102
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Foot Health Status Questioner (FHSQ) PAIN
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks, 26 weeks, 52 weeks
Secondary outcomes:
measure: VAS Maximum
timeFrame: 1st session (baseline), 2nd session (week 2), 3rd session (week 3), 4th session (week 4)
measure: The Quality of Life (QoL) Will be Assessed With the EuroQoL-5 Dimensions (EQ-5D)
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks, 26 weeks, 52 weeks"
Other outcomes:
Locations:
city: Kuwait
country: Kuwait
facility: Physical Medicine and rehabilitation Kuwait
Study officials:
References:
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.
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.
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.