- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06248853
Effect of Graston Technique on Planter Thickness in Patients With Planter Fasciitis (PF)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Plantar fasciitis (PF), generally a self-limiting condition, is identified as one of the most common causes of heel pain in adults. It affects both sedentary and athletic populations .
It may be considered that PF emerges due to excessive and prolonged standing or running, which causes an acute inflammation or micro-tears, and degenerative changes plantar fascia. The persistence of these risk factors inhibits the regular repair process thus collagen degeneration occurs, causing the structural changes of the plantar fascia. Numerous interventions have been described for treatment of PF, which include: Stretching calf or plantar region which is performed with the patient stands with staggered legs facing toward a wall, with both hands stretched out .The Graston technique can break up scar tissue and restore soft tissue. The Graston technique is a type of manual therapy in which patented stainless-steel instruments are used to restore soft tissue motion by breaking up scar tissue. fifty patients with planter fasciitis will be assigned randomly to two equal groups; first one will receive graston technique in addition to exercise program, the second one will receive exercise program only for six weeks
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: mostafa elshenawy, master
- Phone Number: 01124009013
- Email: melshenawy584@gmail.com
Study Contact Backup
- Name: mohamed elgendy, professor
- Phone Number: 01005747169
- Email: prof.mgendy@hotmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- patients that Clinically diagnosed cases of plantar fasciitis not less than 6 weeks.
- patients willing to precipitate in the study and take treatment for 6 successive weeks.
- Heel pain felt maximally over the plantar aspect of heel
- Pain in the heel on the first step in the morning
- No history of rest pain in the heel
Exclusion Criteria:
- Subjects with clinical disorders where therapeutic ultrasound is contraindicated such as infective conditions of foot, tumor, calcaneal fracture, metal implant around ankle.
- Subjects with a clinical disorder where myofascial release is contraindicated as dermatitis.
- Subjects with impaired circulation to lower extremities
- Subjects with referred pain due to sciatica and other neurological disorders.
- Arthritis
- Corticosteroids injection in heel preceding 3 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Garston technique
the patients will receive graston technique with exercise program three times aweek for six weeks
|
the patients will receive instrumented assisted soft tissue mobilization using the Graston technique, which includes the 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 used to mobilize the tissues of the triceps surae and plantar foot bypassing the tools along the leg and foot
the patients will receive pedaling an exercise bicycle for 5 min with minimal resistance to warm the tissues, gastrocnemius stretches performed on a step for three repetitions held for 30 sec each , plantar fascia stretching performed in a seated position for three repetitions held for 30 sec each, and foot intrinsic muscular strengthening using a short foot exercise.
Ice will be offered as needed for pain management after each session in addition to home program exercise
|
Active Comparator: exercise program
the patients will receive an exercise program three times a week for six weeks
|
the patients will receive pedaling an exercise bicycle for 5 min with minimal resistance to warm the tissues, gastrocnemius stretches performed on a step for three repetitions held for 30 sec each , plantar fascia stretching performed in a seated position for three repetitions held for 30 sec each, and foot intrinsic muscular strengthening using a short foot exercise.
Ice will be offered as needed for pain management after each session in addition to home program exercise
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
plantar thickness
Time Frame: up to six weeks
|
Ultrasonography will be used to measure planter thickness
|
up to six weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pain intensity
Time Frame: up to six weeks
|
Visual Analogue Scale (VAS) will be used to assess pain intensity: The VAS is a 100-mm horizontal line that may be used to quantify symptoms in a continuous fashion.
Patients will instructed to indicate the intensity of their pain by marking on a line anchored by "no pain" on the left and "worst imaginable pain" on the right .
|
up to six weeks
|
pain intensity at the first step
Time Frame: up to six weeks
|
numerical pain rating scale (NPRS) will be used to measure pain intensity at the first step.
NPRS is a 10cm horizontal line t.
Patients will instructed to indicate the intensity of their pain by marking on a line anchored by "no pain" on the left and "worst imaginable pain" on the right side.
|
up to six weeks
|
functional levels of foot
Time Frame: up to six weeks
|
The Foot and Ankle Ability Measure (FAAM) questionnaire will be used to assess foot function.
The FAAM is a self-reported questionnaire that comprehensively assesses the physical function of those with musculoskeletal conditions of the leg, foot, and ankle.
It has a 21-item subscale for measuring the function of the individual with his or her activities of daily living (ADLs) and a ten-item subscale for measuring function with sports.
The ADL subscale will be used for this study.
The instrument is scored on a Likert scale from 4 to 0, with 4 representing ''no difficulty'' as going up stairs and 0 representing ''unable to do.''
The answers are then converted to a scale from 0 to 100, with a higher score representing a higher functional level.
|
up to six weeks
|
pain pressure threshold
Time Frame: up to six weeks
|
The pressure algometer device will be used to measure pain pressure threshold
|
up to six weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/002947
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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