Clinical trial NCT02895698: Effects of Myofascial Trigger Point Dry Cupping on Plantar Heel Pain
Official title: Effects of Myofascial Trigger Point Dry Cupping on Plantar Heel Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plantar Fasciitis
Heel Spur Syndrome
Chronic Plantar Fasciitis
Keywords: Cupping
Dry cupping
Myofascial trigger points
Lead sponsor: Imam Abdulrahman Bin Faisal University
Sponsor class: OTHER
First posted: 2016-09-12
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Visual analogue scale (VAS)
timeFrame: Change from Baseline in VAS at 5 minutes post intervention
measure: Visual analogue scale (VAS)
timeFrame: Change from Baseline in VAS at 2 days post intervention
measure: Morning first steps visual analogue scale
timeFrame: Change from Baseline in morning visual Analog Scale at 2 days post intervention
measure: Pressure pain threshold (PPT)
timeFrame: Change from Baseline in PPT at 5 minutes post intervention
measure: Pressure pain threshold (PPT)
timeFrame: Change from Baseline in PPT at 2 days post intervention
measure: The patient-specific functional scale (PSFS)
timeFrame: Change from Baseline in PSFS at 2 days post intervention
measure: Ankle dorsiflexion range of motion (ROM)
timeFrame: Change from Baseline in ankle dorsiflexion ROM at 5 minutes post intervention
measure: Ankle dorsiflexion range of motion (ROM)
timeFrame: Change from Baseline in ankle dorsiflexion ROM at 2 days post intervention
measure: Ankle plantar flexion strength
timeFrame: Change from Baseline in ankle plantar flexion strength at 5 minutes post intervention
measure: Ankle plantar flexion strength
timeFrame: Change from Baseline in ankle plantar flexion strength at 2 days post intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Imam Abdulrahman Bin Faisal University
name: Ali M Al Shami, Ph.D
role: STUDY_DIRECTOR
References:
citation: Crawford F, Thomson C. Interventions for treating plantar heel pain. Cochrane Database Syst Rev. 2003;(3):CD000416. doi: 10.1002/14651858.CD000416.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Messier SP, Pittala KA. Etiologic factors associated with selected running injuries. Med Sci Sports Exerc. 1988 Oct;20(5):501-5.
citation: 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.
citation: 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.
citation: 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.