Effects of Graston Assisted Soft Tissue Mobilization in Patients With Chronic Plantar Fasciitis.

September 13, 2021 updated by: Riphah International University

study was conducted to check the effectiveness of graston on patients with chronic plantar fasciitis. After screening from inclusion exclusion criteria.Data will be randomly divided in two groups.

Graston assisted release of plantar fascia is used for soft tissue mobilization. Pain level using NPRS, score on FADI and dorsiflexion restriction using LUNGE test will be performed before any treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Plantar fasciitis is one of the most common cause of pain in foot and calf areas effecting up to 10% of the total population.(1) On assessment of such patients pain on calcaneal tuberosity on passive dorsiflexion is very common.(2) Common features include sharp stabbing pain specially in morning which subsides after brief walking but may return after prolong period of weight bearing and walking.In general, plantar fasciitis occurs when the plantar fascia is injured from too much pressure or activity, but there is often not a clear cause or triggering event(3)People who are overweight and people who have tight calf muscles, high-arched feet, or flat feet are at risk of plantar fasciitis(4).

Simple measures can often be taken to lessen the symptoms of plantar fasciitis(5). If a clear cause such as a sudden increase in high-impact exercise can be identified, then decreasing the amount of physical activity may be helpful.(6)Daily stretching of the plantar fascia and the calf muscles should be performed, and ice can be applied to the affected area for 10 to 20 minutes at a time 2 to 3 times per day. Wearing shoes with good arch supports can also improve symptoms, and taping the bottom of the feet or using shoe inserts called orthotics are other ways to provide additional foot support. .(6) Over-the-counter anti-inflammatory medications such as ibuprofen may provide short-term relief(7). If pain persists, steroid injections may be given into the foot to reduce the pain. Although most people experience improvement or resolution of symptoms over time, surgery may be considered in rare cases if the pain does not improve after several months of conservative treatments(8). Graston is a used for soft tissue mobilization. Graston Technique is performed by specifically designed stainless steel instruments with beveled edges to perform soft tissue mobilization graston is used in a multi direction strokes on skin at a 30° to 60° angle to the treatment site(8)This technique allows the clinician to feel irregularities in the soft tissue texture through the movement of the gliding tools(8)In addition to removing scar tissue adhesions, Graston instruments have been applied to boost the proliferation of extracellular matrix fibroblasts, improve ion transport, and decrease cell matrix adhesions as has been hypothesized with transverse frictional massage and extra corporeal shock wave therapy.(6)Studies have shown that the controlled micro trauma induced through GT increased fibroblasts recruitment and activation in an animal model. Additional studies have shown clinical efficacy using GT for the treatment of carpal tunnel syndrome, lumbar compartment syndrome(7) and trigger thumb(8). Graston instrument has been used for relieving pressure of soft tissue mobilization and release very effectively for years. It is used by manual therapist and is also known as instrument assisted soft tissue mobilization(IASTM). The instruments are specially designed for manual therapist to identify the areas of adhesion in soft tissue and focus on the release.As proved by Carey-Loghmani and Hammer the GISTM is used to detect and treat soft tissue lesions.The application of the GISTM initiates the inflammatory process, which allows for healing and scar tissue remodeling to take place(9). Although a recent systematic review have reported on current evidence to support the use of conservative interventions for individuals identified as having CPHP. Martin et al reported that soft-tissue mobilization procedures should also be considered in the plan of care for individuals with CPHP(10).

Recent research suggests that plantar "fasciitis" manifests itself as a noninflammatory degenerative process, and hence, the term fasciosis may be more appropriate.(6) Brian looney et al proved graston to be an effective tool to increase pain and dorsiflexion range in patients with plantar fasciitis through case series(11). The authors reported that the participants demonstrated clinically meaningful improvements in pain ratings and functional improvements in Global Rating of Change Scale and Lower Extremity Functional Scale scores(11)Daniels and Morrell reported the effectiveness of using the Graston technique to perform IASTM in addition to joint manipulation to manage a 10-year-old male athlete with bilateral plantar fasciitis(12). In addition, the biologic evidence that suggests that PF is not truly an inflammatory condition but one of fibrosis supports the theorized mechanism behind the graston(2) .Perhaps the use of instruments allows the clinician to introduce a more controlled amount of micro trauma into an area of scar tissue or excessive fibrosis(8). Research suggests that the response of this microtrauma would result in the healing process by initiating inflammatory phase of healing and, ultimately, tissue remodeling through proper realignment of collagen fibers(11).A pilot study by Edward R. Jones et al demonstrates that inclusion of IASTM using the Graston technique for chronic plantar heel pain lasting longer than 6 weeks is a feasible intervention warranting further study(13). Andrew L. Miners and Tracy L. Bougie showed a specific protocol of heat, graston assisted soft tissue mobilization, eccentric exercise, stretching, and cryotherapy appeared to facilitate a rapid and complete recovery from chronic Achilles tendinopathy(14).

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Fedral
      • Islamabad, Fedral, Pakistan, 44000
        • Rawal General And Dental Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

The study includes patients from the age group of 35 to 50 years.

  • The study includes patients with plantar heel pain from more than 6 weeks
  • The study includes patients with restricted dorsiflexion which will be measured by lunge's test
  • Pain in morning (decrease with activity)

Exclusion Criteria:

  • The study acute patient with plantar pain.
  • No history of serious underlying pathology, nerve root compromise, structural deformities, genetic spinal disorders or previous spinal surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Experimental: B (exercise + graston):

In graston + exercises treatment will be same but after exercises added with proper application of graston which included application of a cream to the posterior calf and plantar foot from the knee to the toes to reduce friction on the skin.The Graston tools will be then used to mobilize the tissues of the triceps surf and plantar foot. In areas of increased tissue restriction, more aggressive pressure with graston was applied using increased force and shorter strokes over the areas of restriction was offered as needed for pain management after each session. This will be continued for three sessions. NPRS score, score on FADI and dorsiflexors range will be assessed after treatment of two weeks. Along with conventional treatment.

.
Other: Exercise + Graston.

In graston + exercises treatment will be same but after exercises added with proper application of graston which included application of a cream to the posterior calf and plantar foot from the knee to the toes to reduce friction on the skin.The Graston tools will be then used to mobilize the tissues of the triceps surae and plantar foot. In areas of increased tissue restriction, more aggressive pressure with graston was applied using increased force and shorter strokes over the areas of restrictionIce was offered as needed for pain management after each session. This will be continued for three sessions. NPRS score, score on FADI and dorsiflexors range will be assessed after treatment of two weeks. Along with conventional treatment.

.

Other Names:
  • exercise only
Active Comparator: A (exercise only)
Exercises only. Patients will be given gastrocnemius stretching, plantar fascia stretching, myofascial release and then graston will be given as sham treatment for 10 minutes after applying cream (applying graston on skin but not giving enough pressure).
Other: exercise only
gastrocnemius and plantarstretching

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
effects of graston on pain in patients with plantar fasciitis.
Time Frame: 6 months
Pain will be evaluated by NPRS on scale of to 10
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
effects of graston on range of motion in patients with plantar fasciitis.
Time Frame: 6 months
Range of motion will be calculated by Lunge test.
6 months
effects of graston assisted soft tissue mobilization on Foot and ankle function and disability.
Time Frame: 6 months
Will be calculated by Foot and ankle disability Index.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2021

Primary Completion (Actual)

July 30, 2021

Study Completion (Actual)

July 31, 2021

Study Registration Dates

First Submitted

June 11, 2021

First Submitted That Met QC Criteria

August 5, 2021

First Posted (Actual)

August 6, 2021

Study Record Updates

Last Update Posted (Actual)

September 20, 2021

Last Update Submitted That Met QC Criteria

September 13, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/00869 Maham Nasir

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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