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Effects of Myofascial Trigger Point Dry Cupping on Plantar Heel Pain

Primary Purpose

Plantar Fasciitis, Heel Spur Syndrome, Chronic Plantar Fasciitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dry cupping
Stretching exercises
Sponsored by
Imam Abdulrahman Bin Faisal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plantar Fasciitis focused on measuring Cupping, Dry cupping, Myofascial trigger points

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Other

    Arm Label

    Treatment group

    Control group

    Arm Description

    Dry cupping + active dorsiflexion exercise + stretching exercise

    stretching exercise + active dorsiflexion without cupping

    Outcomes

    Primary Outcome Measures

    Visual analogue scale (VAS)
    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.
    Visual analogue scale (VAS)
    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
    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)
    The PPT was measured with an electronic algometer. Pressure was applied at a rate of 40 kilopascal (kPa/s), and participants pressed a switch when the sensation changed from pressure only to pressure and pain.
    Pressure pain threshold (PPT)
    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.
    The patient-specific functional scale (PSFS)
    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)
    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.
    Ankle dorsiflexion range of motion (ROM)
    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.
    Ankle plantar flexion strength
    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.
    Ankle plantar flexion strength
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 6, 2016
    Last Updated
    September 6, 2016
    Sponsor
    Imam Abdulrahman Bin Faisal University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02895698
    Brief Title
    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

    2. Study Status

    Record Verification Date
    September 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2014 (undefined)
    Primary Completion Date
    October 2015 (Actual)
    Study Completion Date
    October 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Imam Abdulrahman Bin Faisal University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Plantar Fasciitis, Heel Spur Syndrome, Chronic Plantar Fasciitis
    Keywords
    Cupping, Dry cupping, Myofascial trigger points

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    70 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment group
    Arm Type
    Active Comparator
    Arm Description
    Dry cupping + active dorsiflexion exercise + stretching exercise
    Arm Title
    Control group
    Arm Type
    Other
    Arm Description
    stretching exercise + active dorsiflexion without cupping
    Intervention Type
    Device
    Intervention Name(s)
    Dry cupping
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Stretching exercises
    Intervention Description
    The participant was in prone with the ankle outside the edge of the bed. The participant was asked to do active ankle dorsiflexion exercise after 5 minutes of lying on bed. Standing self-stretching of the calf muscles. Plantar fascia-specific self-stretching.The participant was instructed to start gently at first and then to work more aggressively as long as the pain is tolerable. All stretches were done six times and the duration of each stretch is 30 seconds.
    Primary Outcome Measure Information:
    Title
    Visual analogue scale (VAS)
    Description
    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.
    Time Frame
    Change from Baseline in VAS at 5 minutes post intervention
    Title
    Visual analogue scale (VAS)
    Description
    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.
    Time Frame
    Change from Baseline in VAS at 2 days post intervention
    Title
    Morning first steps visual analogue scale
    Description
    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.
    Time Frame
    Change from Baseline in morning visual Analog Scale at 2 days post intervention
    Title
    Pressure pain threshold (PPT)
    Description
    The PPT was measured with an electronic algometer. Pressure was applied at a rate of 40 kilopascal (kPa/s), and participants pressed a switch when the sensation changed from pressure only to pressure and pain.
    Time Frame
    Change from Baseline in PPT at 5 minutes post intervention
    Title
    Pressure pain threshold (PPT)
    Description
    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.
    Time Frame
    Change from Baseline in PPT at 2 days post intervention
    Title
    The patient-specific functional scale (PSFS)
    Description
    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.
    Time Frame
    Change from Baseline in PSFS at 2 days post intervention
    Title
    Ankle dorsiflexion range of motion (ROM)
    Description
    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.
    Time Frame
    Change from Baseline in ankle dorsiflexion ROM at 5 minutes post intervention
    Title
    Ankle dorsiflexion range of motion (ROM)
    Description
    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.
    Time Frame
    Change from Baseline in ankle dorsiflexion ROM at 2 days post intervention
    Title
    Ankle plantar flexion strength
    Description
    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.
    Time Frame
    Change from Baseline in ankle plantar flexion strength at 5 minutes post intervention
    Title
    Ankle plantar flexion strength
    Description
    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.
    Time Frame
    Change from Baseline in ankle plantar flexion strength at 2 days post intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ali M Al Shami, Ph.D
    Organizational Affiliation
    Imam Abdulrahman Bin Faisal University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    12917892
    Citation
    Crawford F, Thomson C. Interventions for treating plantar heel pain. Cochrane Database Syst Rev. 2003;(3):CD000416. doi: 10.1002/14651858.CD000416.
    Results Reference
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    PubMed Identifier
    17442119
    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.
    Results Reference
    background
    PubMed Identifier
    22820618
    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.
    Results Reference
    background
    PubMed Identifier
    16584917
    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.
    Results Reference
    background
    PubMed Identifier
    17400020
    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.
    Results Reference
    background
    PubMed Identifier
    3193867
    Citation
    Messier SP, Pittala KA. Etiologic factors associated with selected running injuries. Med Sci Sports Exerc. 1988 Oct;20(5):501-5.
    Results Reference
    background
    PubMed Identifier
    21285525
    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.
    Results Reference
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    PubMed Identifier
    12728038
    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. Erratum In: J Bone Joint Surg Am. 2003 Jul;85-A(7):1338.
    Results Reference
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    PubMed Identifier
    25361863
    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.
    Results Reference
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    Effects of Myofascial Trigger Point Dry Cupping on Plantar Heel Pain

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