- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02895698
Effects of Myofascial Trigger Point Dry Cupping on Plantar Heel Pain
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Treatment group
Dry cupping + active dorsiflexion exercise + stretching exercise
|
Dry cupping.
First, the therapist identified the trigger point on calf muscle.After identification of the trigger point, the participant was in prone with the ankle outside the edge of the bed.
Ultrasound gel was then placed over the trigger point as a lubricant to increase the suctioning of the plastic vacuum cup, after which the cup was placed.
Air was withdrawn from the cup to create a suction force.
The cup was maintained for 10 minutes, and the participant was asked to do active ankle dorsiflexion exercise after 5 minutes of placing the cup.
The therapist held the cup in place while the participant performed exercise.
|
Other: Control group
stretching exercise + active dorsiflexion without cupping
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual analogue scale (VAS)
Time Frame: Change from Baseline in VAS at 5 minutes post intervention
|
|
Change from Baseline in VAS at 5 minutes post intervention
|
Visual analogue scale (VAS)
Time Frame: Change from Baseline in VAS at 2 days post intervention
|
|
Change from Baseline in VAS at 2 days post intervention
|
Morning first steps visual analogue scale
Time Frame: Change from Baseline in morning visual Analog Scale at 2 days post intervention
|
|
Change from Baseline in morning visual Analog Scale at 2 days post intervention
|
Pressure pain threshold (PPT)
Time Frame: Change from Baseline in PPT at 5 minutes post intervention
|
|
Change from Baseline in PPT at 5 minutes post intervention
|
Pressure pain threshold (PPT)
Time Frame: Change from Baseline in PPT at 2 days post intervention
|
|
Change from Baseline in PPT at 2 days post intervention
|
The patient-specific functional scale (PSFS)
Time Frame: Change from Baseline in PSFS at 2 days post intervention
|
|
Change from Baseline in PSFS at 2 days post intervention
|
Ankle dorsiflexion range of motion (ROM)
Time Frame: Change from Baseline in ankle dorsiflexion ROM at 5 minutes post intervention
|
|
Change from Baseline in ankle dorsiflexion ROM at 5 minutes post intervention
|
Ankle dorsiflexion range of motion (ROM)
Time Frame: Change from Baseline in ankle dorsiflexion ROM at 2 days post intervention
|
|
Change from Baseline in ankle dorsiflexion ROM at 2 days post intervention
|
Ankle plantar flexion strength
Time Frame: Change from Baseline in ankle plantar flexion strength at 5 minutes 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.
|
Change from Baseline in ankle plantar flexion strength at 5 minutes post intervention
|
Ankle plantar flexion strength
Time Frame: 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.
|
Change from Baseline in ankle plantar flexion strength at 2 days post intervention
|
Collaborators and Investigators
Investigators
- Study Director: Ali M Al Shami, Ph.D, Imam Abdulrahman Bin Faisal University
Publications and helpful links
General Publications
- Martin RL, Davenport TE, Reischl SF, McPoil TG, Matheson JW, Wukich DK, McDonough CM; American Physical Therapy Association. Heel pain-plantar fasciitis: revision 2014. J Orthop Sports Phys Ther. 2014 Nov;44(11):A1-33. doi: 10.2519/jospt.2014.0303.
- Crawford F, Thomson C. Interventions for treating plantar heel pain. Cochrane Database Syst Rev. 2003;(3):CD000416. doi: 10.1002/14651858.CD000416.
- Radford JA, Landorf KB, Buchbinder R, Cook C. Effectiveness of calf muscle stretching for the short-term treatment of plantar heel pain: a randomised trial. BMC Musculoskelet Disord. 2007 Apr 19;8:36. doi: 10.1186/1471-2474-8-36.
- Ieong E, Afolayan J, Carne A, Solan M. Ultrasound scanning for recalcitrant plantar fasciopathy. Basis of a new classification. Skeletal Radiol. 2013 Mar;42(3):393-8. doi: 10.1007/s00256-012-1470-x. Epub 2012 Jul 22.
- Irving DB, Cook JL, Menz HB. Factors associated with chronic plantar heel pain: a systematic review. J Sci Med Sport. 2006 May;9(1-2):11-22; discussion 23-4. doi: 10.1016/j.jsams.2006.02.004. Epub 2006 Apr 3.
- Alshami AM, Souvlis T, Coppieters MW. A review of plantar heel pain of neural origin: differential diagnosis and management. Man Ther. 2008 May;13(2):103-11. doi: 10.1016/j.math.2007.01.014. Epub 2007 Mar 30.
- Messier SP, Pittala KA. Etiologic factors associated with selected running injuries. Med Sci Sports Exerc. 1988 Oct;20(5):501-5.
- Renan-Ordine R, Alburquerque-Sendin F, de Souza DP, Cleland JA, Fernandez-de-Las-Penas C. Effectiveness of myofascial trigger point manual therapy combined with a self-stretching protocol for the management of plantar heel pain: a randomized controlled trial. J Orthop Sports Phys Ther. 2011 Feb;41(2):43-50. doi: 10.2519/jospt.2011.3504. Epub 2011 Jan 31.
- Riddle DL, Pulisic M, Pidcoe P, Johnson RE. Risk factors for Plantar fasciitis: a matched case-control study. J Bone Joint Surg Am. 2003 May;85(5):872-7. doi: 10.2106/00004623-200305000-00015. Erratum In: J Bone Joint Surg Am. 2003 Jul;85-A(7):1338.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-2014-04-322
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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