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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06139822
Other study ID # Riphah/RCRS/01223 Sunya Fiaz
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2022
Est. completion date January 25, 2023

Study information

Verified date November 2023
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the study is to compare the effects of Hamstring stretching versus conventional treatment for plantar fasciitis. A randomized control trial was conducted at Cena Medical Center Rawalpindi and Midland Doctors Institute Muzaffarabaad. The sample size was 64 calculated through open-epi tool. The participants were divided into two groups, interventional and control group each having 32 participants. The study duration was 1 year. Sampling technique applied was Purposive sampling for recruitment and group randomization using flip coin method. Only 25to 45 years participants with plantar fasciitis along with hamstring tightness were included in the study. Tools used in this study are Goniometer, Visual Analogue Scale(VAS) for pain, and Functional Foot Index (FFI) for pain and disability. Data was collected before treatment at baseline and after 1st and 2nd week of the application of interventions. Data analyzed through SPSS version 25.


Description:

Plantar fasciitis is one of the main causes of heel pain. it is caused by the micro trauma to the site of attachment of plantar fascia at its origin on the medial tubercle of calcaneus resulting in inflammation. Plantar fascia is a fibrous band present at the bottom of foot which attaches heel to each of the toes.plantar fascia has a windlass mechanism which continuously stretches and shortens facilitating foot movements during walk. During the standing phase all the tension forces are gathered at calcaneal tuberosity, which is a site of attachment for plantar fascia on heel. Pain is generally present at the medial side of heel to the medial arch of the foot. Plantar fasciitis is often caused in people who have long periods of standing, involved in activities like running, jumping or other repeated activities. After knowing the exact mechanism it is suggested that it should be termed as planter fasciosis.Plantar fasciitis accounts for almost 80% of the total heel pain experienced by the people. Planter fasciitis is treated with various treatment options. Initially it is treated by conservative treatments such as, rest, ice massage, foot ware modification, oral analgesics, stretching techniques, physical therapy modalities, and night splinting. If pain do not resolve with conservative treatment then further treatment options will be extracorporeal shock wave therapy, cortisone injections and surgery. Diana et al concluded that addition of manual techniques for trigger point release along with stretching of plantar fascia is more effective than stretching alone. In a randomized control trial with a follow up of 12 months high load strength training was found to be quicker and more efficient treatment for plantar fasciitis. another RCT conducted in 2017 reported that stretching of Achilles tendon along with plantar fascia is twice effective than only plantar fascia stretching. Immobilization done by using splints at night is one of the best treatments to avoid contracture in plantar fascia during night. But they are also related to sleep disturbances and discomfort during night. By using night splint there has been a pain relief for shorter period of time. Night splints used alongside custom foot orthotics have better results than used alone. Controlled Ankle Movement is very effective in reducing pain in heel. It can be done by using walking boots and casts. These boots and casts will help to reduce over stretching of plantar fascia with unloading mechanism over heel. The reported reduction of pain by this mechanism of controlled ankle movement is in up to 40% of individuals. Jonathan et al reported that there is a role of hamstring tightness in plantar fasciitis. A correlation study found a strong relationship between hamstring tightness and plantar fasciitis. patients having hamstring tightness are 8.7% more prone towards developing planter fasciitis. Hamstring is found to be affected in patients with plantar fasciitis. Many studies found relationship of hamstring tightness with plantar fasciitis. Hamstring tightness affects the posterior muscles increasing load on plantar fascia. There is scarce evidence about the hamstring stretching in patients having plantar fasciitis. So this study will focus on hamstring stretching along with plantar fascia stretching and strengthening to improve pain, range of motion and disability.


Recruitment information / eligibility

Status Completed
Enrollment 64
Est. completion date January 25, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 25 Years to 45 Years
Eligibility Inclusion Criteria: 1. Both Genders 2. 25 to 45 years of age 3. Participants having heel pain for more than one month. 4. Participants having Windlass positive test. 5. Participants having hamstring tightness. 6. sit and reach test positive. 7. Bilateral plantar fasciitis. Exclusion Criteria: - Patients with corticosteroid injection - Fracture around ankle and Calcaneal - Any soft tissue injuries around ankle. - Other Neurological/ Musculoskeletal disorder - Congenital foot anomalies - Systemic medical illness

Study Design


Intervention

Other:
Experimental Group
Hamstring stretching is the main intervention which is being used along with convention protocol for plantar fasciitis.
Control Group
Control group included Cold pack for 7 to 10 mins. Followed by stretching of plantar fascia .

Locations

Country Name City State
Pakistan Riphah International University Islamabad Federal

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Visual Analogue Scale (VAS) The visual analogue scale (VAS) is a scale that is used as a questionnaire. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end points.patient rates its pain between 0 to 10.
VAS Visual Analogue Scale changes measured at baseline after 1 week and sfter 2nd week.
upto 2 weeks
Secondary Goniometery for ROM(Range of Motion) The art and science of measuring the joint ranges in each plane of the joint are called goniometry. Goiniometer is used to measure ankle range of motions specifically dorsiflexion and plantar flexion.
Changes from the Baseline ROM range of Motion of ankle in plantar flexion was taken with the Help of goniometer. Changes from the Baseline ROM range of Motion of ankle in plantar flexion was taken with the Help of goniometer and after 1st and 2nd week
upto 2 weeks
Secondary Functional Foot Index (FFI-R) A Foot Function Index (FFI-R) was developed to measure the impact of foot pathology on function in terms of pain, disability and activity restriction. The FFI-R is a self-administered index consisting of 68 items divided into 4 sub-scales. Both total and sub-scale scores are produced.
Functional Foot Index (FFI-R) is used to measure activity status and disability index at baseline and after every week.
upto 2 weeks
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