- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06877767
Graston Versus Active Release Technique in Females With Non Specific Low Back Pain
Effects of Graston Versus Active Release Technique on Hamstring Flexibility, Pain and Disability in Females With Non Specific Low Back Pain
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Low back pain (LBP) is a condition experienced at least once by more than 80% of the human race the world over. More than 85% of cases of LBP in the USA are classified as nonspecific LBP defined by tension, soreness, and/or stiffness of the lower back with unknown origins of pain. Non-specific low back pain (NLBP) or "simple backache" is characterized as an LBP not due to any identifiable disease such as nerve root pain and severe spinal pathologies such as infection, tumor, osteoporosis, rheumatoid arthritis, fracture or inflammation. Back pain causes decreased lumbar extensibility, limited range of motion (LOM) and gait ability, and change of rhythm in the pelvis, limitations that can restrict social activities. One of the most widely studied outcomes in LBP patients is the reduction of hamstring extensibility. A shortening of the hamstring may result in LOM of the knee joint, restricting a person's ability to walk and run. In addition, it increases posterior pelvic tilting and reduces lumbar lordosis, contributing to a flat back that can result in low back. Methods for increasing the length of the shortened hamstring include stretching, eccentric resistance exercise, Graston instrument soft tissue mobilization, and self-myofascial release. Hamstring tightness is prevalent with the low back pain yet there is a need to establish a standardized treatment protocol for the condition. That's why this study will try to find out effective manner to release the pain and improve the flexibility of hamstring muscles.
The aim of this study is to determine the comparative effects of ART and Graston Technique specifically with each other on Hamstring flexibility, pain and disability in females with nonspecific low back pain. Therefore, this study will put into effect so that Graston Technique and ART can be compared against each other to see if one is more effective for restoration of full soft tissue function and relieving pain. This study will provide significant information that will aid in the creation of therapeutic interventions to improve pain, range of motion and functional limitations in females with non-specific low back pain. Graston Technique (GT) is a soft tissue mobilization treatment method using a tool that generates mechanical micro-traumatic damage to the treated area. In ART the goal is to remove the soft tissue adhesions by decreasing tissue tension. The muscle is taken from a shortened position to a lengthened position while a contact hand is holding tissue tension longitudinally along the soft tissue fibers.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Imran Amjad, PHD*
- Phone Number: 03324390125
- Email: imran.amjad@riphah.edu.pk
Study Contact Backup
- Name: Imran Amjad, PHD*
- Phone Number: 0515481826
- Email: imran.amjad@riphah.edu.pk
Study Locations
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Punjab
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Sialkot, Punjab, Pakistan
- Recruiting
- Allama Iqbal memorial teaching hospital
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Contact:
- Ghulam Fatima, PhD*
- Phone Number: 03034073057
- Email: ghulam.fatima@riphah.edu.pk
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Principal Investigator:
- Aneesa Javaid, MS*
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Females with Non Specific Low Back Pain
- Age group between 25 and 50 years
- History of NSLBP for at least 3 months
- Popliteal angle Numeric Rating Scale (NRS) score of 3-7/10
- The Oswestry Disability Index (ODI) score of 20-60
- Patients agree to sign written consent form.
Exclusion Criteria:
- Acute onset of pain and pain with radiation below knee.
- Any history of injury in the lower extremity in the past three months.
- Constant or persistent severe pain, inflammatory conditions (rheumatoid arthritis, ankylosing spondylitis)
- participants must not be taking any treatment of a musculoskeletal nature.
- Any previous surgery around the knee and hip
- hamstrings injury and strains
- Pregnant females
- Allergy to hot pack
Study Plan
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: Group A: graston technique
Group A: baseline physical therapy treatment along with graston technique
|
Following the conventional treatment, this technique will be carried out through Graston tool called "GT-1" The special Graston Emollient or lubricant will be applied to the hamstrings of the subject then the tool used to find adhesions and break them up for 2.5 minutes per leg.
First, the subject will lay prone and bent the knee joint to around 30° to 60°.The Graston instrument will be rubbed on each subject 30 times for 60 seconds from the gluteal line to the popliteal fossa.
This treatment technique will be applied twice a week
|
|
Active Comparator: Group B: active release technique
Group B: baseline physical therapy treatment along with active release technique
|
Following the conventional treatment, subject received single session of ART on each side.
There are 3 steps to perform ART.
Step 1:Subject lies supine on the plinth and gentle tension was applied to the hamstring muscle along the entire length while stretching the leg in different positions to better work the muscle.
Step 2: Gentle tension will be applied at the origin and insertion of the hamstring muscle.
Step 3: The therapist will place tension on the bellies of hamstrings longitudinally at a specific tension & ask the patient to extend his knee as per ART protocol.•
This is done for 2.5 minutes on each leg.
• This treatment technique will be applied twice a week.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Oswestry Disability Index
Time Frame: 4 weeks
|
Oswestry Disability Questionnaire will be used for measuring the level of disability in patients with low back pain.
This questionnaire consists of 10 categories, each of which score on scale of 0-5, where 0 shows no disability and 5 shows the greatest disability.
Each section caries 05 Questions describing minimum to maximum level of disability.
The test is considered the 'gold standard' of low back functional outcome tools.
It has 10 different sections.
For each section the total possible score is 5.
If all 10 sections are completed the score is calculated and interpreted in percentage measures.
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4 weeks
|
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Universal Goniometer (UG)
Time Frame: 4 weeks
|
Universal Goniometer (UG) is used for the measurement of popliteal angle and active knee extension test.
To measure the popliteal angle, an active knee extension test will be applied.
The the testing limb in 90º hip and knee flexion and the non testing limb in an extended with the subject supine on plinth, with the help of goniometer angle is measured between thigh and calf.
For AKE test participants are positioned supine on a plinth.
From this position, subjects are instructed to extend the knee until they felt a strong resistance, holding this final position for 2 to 3 seconds to allow the goniometric reading .
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4 weeks
|
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Numeric Pain Rating Scale
Time Frame: 4 weeks
|
The NPRS is a standardized self-report device consisting of a horizontal line used to estimate the subjective level of pain intensity.
It is a 10 Points numerical scale, corresponding to the degree of pain. 1 being least level of pain and 10 being the highest level of pain.
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4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ghulam Fatima, PHD*, Riphah International University
Publications and helpful links
General Publications
- Moon JH, Jung JH, Won YS, Cho HY. Immediate effects of Graston Technique on hamstring muscle extensibility and pain intensity in patients with nonspecific low back pain. J Phys Ther Sci. 2017 Feb;29(2):224-227. doi: 10.1589/jpts.29.224. Epub 2017 Feb 24.
- Allam NM, Eladl HM, Elruwaili LT, Elruwaili LF, Elbenya TJ, Elanzi EM, Elquobisi FF, Elgadoa HM, Elghaleb MA, Elsaeid MS, Elquarenes RA, Elrashed SM, Elmobarak SS, Elkholi SM, Eid MM, Alanazi AM, Nambi G, Abdelbasset WK. Correlation between hamstring muscle tightness and incidence of low back pain in female students at Jouf University, Saudi Arabia. Eur Rev Med Pharmacol Sci. 2022 Nov;26(21):7779-7787. doi: 10.26355/eurrev_202211_30127.
- Nazary-Moghadam S, Yahya-Zadeh A, Zare MA, Ali Mohammadi M, Marouzi P, Zeinalzadeh A. Comparison of utilizing modified hold-relax, muscle energy technique, and instrument-assisted soft tissue mobilization on hamstring muscle length in healthy athletes: Randomized controlled trial. J Bodyw Mov Ther. 2023 Jul;35:151-157. doi: 10.1016/j.jbmt.2023.04.079. Epub 2023 Apr 21.
- Sassonker K, Magnezi R, Moran D. Comparing right and left hamstring flexibility and its association to nonspecific lowr back pain among women of different age groups. J Bodyw Mov Ther. 2023 Oct;36:404-409. doi: 10.1016/j.jbmt.2023.07.014. Epub 2023 Sep 9.
- Hori M, Hasegawa H, Takasaki H. Comparisons of hamstring flexibility between individuals with and without low back pain: systematic review with meta-analysis. Physiother Theory Pract. 2021 May;37(5):559-582. doi: 10.1080/09593985.2019.1639868. Epub 2019 Jul 18.
Study record dates
Study Major Dates
Study Start (Actual)
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
- REC/RCR & AHS/24/0148
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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