Effects of Myofascial Trigger Point Dry Cupping on Plantar Heel Pain

Not Applicable

Completed

• Conditions: Heel Spur Syndrome; Chronic Plantar Fasciitis; Plantar Fasciitis
• Interventions: Device: Dry cupping; Other: Stretching exercises

• Registration Number: NCT02895698
• Lead Sponsor: Imam Abdulrahman Bin Faisal University

Brief Summary

The main aim of this study is to investigate the effects of dry cupping on calf muscle trigger points in patients with plantar heel pain. A secondary aim is to examine the correlation between several outcome measures in those patients.

Detailed Description

Plantar heel pain is a condition often seen by healthcare providers. It is presented as pain and tenderness under the heel with weight bearing activities. Approximately 15% of athletic and non-athletic adults who have foot complaints seek professional care for plantar heel pain. There are different names and definitions for this condition in the literature such as plantar heel pain, plantar fasciitis, plantar fasciosis, plantar fasciopathy, heel spur syndrome, and jogger's heel. The reason for inconsistency in defining the condition is due to disagreement on the underlying pathology. A number of conditions may result in plantar heel pain, namely plantar fasciitis (most common), calcaneus fracture, heel fat pad atrophy, and peripheral nerve dysfunction. Recently, several studies have shown that myofascial trigger points (MTrPs) or tender points in the calf muscles may be associated with plantar heel pain. Many studies have determined risk factors in the development of plantar heel pain, classifying them as either intrinsic or extrinsic. Intrinsic risk factors comprise the anatomical (ROM of the ankle and subtalar joints position) or demographic characteristics of the individual (age, gender, weight and height). Extrinsic risk factors are related mainly to the subject's activity environment, such as running on a hard surface, time spent weight bearing, and previous injury. All these factors lead to an increase in the mechanical load on the foot, specifically the plantar fascia. Treatment of plantar heel pain usually targets the plantar fascia or other structures in the plantar heel area using several interventions such as cortisone injection, therapeutic ultrasound, laser, ice, heel pads, and night splints. Evidence varies regarding the effectiveness of these interventions.

The main aim of this study is to investigate the immediate and carry-over effects of dry cupping on calf muscle trigger points on pain and function in patients with plantar heel pain.

Study Timeline

• Study Start: 2014-11
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2016-09
• Study First Submitted: 2016-09-06
• Study First Submitted QC: 2016-09-06
• Last Update Submitted: 2016-09-06
• Study First Posted: 2016-09-12
• Last Update Posted: 2016-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Unilateral plantar heel pain.
• Trigger point(s) in the gastrocnemius/soleus muscle(s).
• Central or centro-medial tenderness in the plantar aspect of the heel.

Exclusion Criteria

• Red flags: tumor, fracture, rheumatoid arthritis, osteoporosis, or any severe vascular condition in the lower limbs.
• Neurological symptoms: sciatica, tarsal tunnel syndrome.
• Previous surgery in the affected leg below the hip.
• Fibromyalgia.
• Previous manual therapy treatment for the same condition within the past 6 months.
• History of more than three corticosteroid injections within the past year.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group	Dry cupping	Dry cupping + active dorsiflexion exercise + stretching exercise
Control group	Stretching exercises	stretching exercise + active dorsiflexion without cupping

Primary Outcome Measures

Name	Time	Method
Visual analogue scale (VAS)	Change from Baseline in VAS at 2 days post intervention	* A self-reporting scale.; * The scale is presented as a 10-cm horizontal line on which the participant pain intensity is represented by a point between the two ends: one end is labelled no pain, and the other end is labelled worst pain imaginable.
Morning first steps visual analogue scale	Change from Baseline in morning visual Analog Scale at 2 days post intervention	* A self-reporting scale.; * The scale is presented as a 10-cm horizontal line on which the participant pain intensity is represented by a point between the two ends: one end is labelled no pain, and the other end is labelled worst pain imaginable.
Pressure pain threshold (PPT)	Change from Baseline in PPT at 2 days post intervention	* The PPT was measured with an electronic algometer.; * Pressure was applied at a rate of 40 kPa/s, and participants pressed a switch when the sensation changed from pressure only to pressure and pain.
Ankle plantar flexion strength	Change from Baseline in ankle plantar flexion strength at 2 days post intervention	Ankle plantar flexion strength was assessed by asking the participant to perform as many single-leg heel rises as possible in standing at a rate of one every 2 seconds, and the examiner counted the repetitions.
The patient-specific functional scale (PSFS)	Change from Baseline in PSFS at 2 days post intervention	* A clinical outcome measure that allows participant to state their own functional status.; * The examiner asked the participant about three important activities that they were unable to do or had difficulty doing. The participants rated their level of function on a scale starting from 0, which is the lowest functional level, and 10, which is the highest level of function.
Ankle dorsiflexion range of motion (ROM)	Change from Baseline in ankle dorsiflexion ROM at 2 days post intervention	* An inclinometer was used to measure the ROM of ankle dorsiflexion.; * The participant stands in a calf-stretch position, with knee extended or knee flexed (modified lunge position) then to move forward until the heel starts to rise or to maximum stretch. Then the examiner measured the range of motion.