NCT02895698

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 12, 2016

Completed
Last Updated

September 12, 2016

Status Verified

September 1, 2016

Enrollment Period

11 months

First QC Date

September 6, 2016

Last Update Submit

September 6, 2016

Conditions

Keywords

CuppingDry cuppingMyofascial trigger points

Outcome Measures

Primary Outcomes (10)

  • 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.

    Change from Baseline in VAS at 5 minutes post intervention

  • 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.

    Change from Baseline in VAS at 2 days post intervention

  • 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.

    Change from Baseline in morning visual Analog Scale at 2 days post intervention

  • 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.

    Change from Baseline in PPT at 5 minutes post intervention

  • 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.

    Change from Baseline in PPT at 2 days post intervention

  • 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.

    Change from Baseline in PSFS at 2 days post intervention

  • 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.

    Change from Baseline in ankle dorsiflexion ROM at 5 minutes post intervention

  • 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.

    Change from Baseline in ankle dorsiflexion ROM at 2 days post intervention

  • 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.

    Change from Baseline in ankle plantar flexion strength at 5 minutes post intervention

  • 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.

    Change from Baseline in ankle plantar flexion strength at 2 days post intervention

Study Arms (2)

Treatment group

ACTIVE COMPARATOR

Dry cupping + active dorsiflexion exercise + stretching exercise

Device: Dry cupping

Control group

OTHER

stretching exercise + active dorsiflexion without cupping

Other: Stretching exercises

Interventions

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.

Treatment group

* 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.

Control group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • Crawford F, Thomson C. Interventions for treating plantar heel pain. Cochrane Database Syst Rev. 2003;(3):CD000416. doi: 10.1002/14651858.CD000416.

    PMID: 12917892BACKGROUND
  • 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.

    PMID: 17442119BACKGROUND
  • 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.

    PMID: 22820618BACKGROUND
  • 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.

    PMID: 16584917BACKGROUND
  • 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.

    PMID: 17400020BACKGROUND
  • Messier SP, Pittala KA. Etiologic factors associated with selected running injuries. Med Sci Sports Exerc. 1988 Oct;20(5):501-5.

    PMID: 3193867BACKGROUND
  • 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.

    PMID: 21285525BACKGROUND
  • 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.

    PMID: 12728038BACKGROUND
  • 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.

    PMID: 25361863BACKGROUND

MeSH Terms

Conditions

Fasciitis, Plantar

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

FasciitisMusculoskeletal DiseasesFoot Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Ali M Al Shami, Ph.D

    Imam Abdulrahman Bin Faisal University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2016

First Posted

September 12, 2016

Study Start

November 1, 2014

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

September 12, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share