Effects of Myofascial Trigger Point Dry Cupping on Plantar Heel Pain

Sponsor

Imam Abdulrahman Bin Faisal University (Other)

Overall Status

Completed

CT.gov ID

NCT02895698

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Plantar Fasciitis Heel Spur Syndrome Chronic Plantar Fasciitis	Device: Dry cupping Other: Stretching exercises	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effects of Myofascial Trigger Point Dry Cupping on Plantar Heel Pain

Study Start Date :

Nov 1, 2014

Actual Primary Completion Date :

Oct 1, 2015

Actual Study Completion Date :

Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Treatment group Dry cupping + active dorsiflexion exercise + stretching exercise	Device: Dry cupping 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	Other: Stretching exercises 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.

Arm

Intervention/Treatment

Active Comparator: Treatment group

Dry cupping + active dorsiflexion exercise + stretching exercise

Device: Dry cupping

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

Other: Stretching exercises

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.

Outcome Measures

Primary Outcome Measures

Visual analogue scale (VAS) [Change from Baseline in VAS at 5 minutes 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.
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 5 minutes post intervention]
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) [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.
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 5 minutes 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.
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.
Ankle plantar flexion strength [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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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.