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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-14

Study Completion Date

2019-12-20

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Plantar Fascitis Myofacial Pain Syndromes Trigger Point Pain, Myofascial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Study Groups

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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.

Group Type EXPERIMENTAL

dry needling

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

dry needling

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Percutaneous needle electrolysis

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes