Clinical trial NCT06877767: Graston Versus Active Release Technique in Females With Non Specific Low Back Pain
Official title: Effects of Graston Versus Active Release Technique on Hamstring Flexibility, Pain and Disability in Females With Non Specific Low Back Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Low Back Pain
Keywords: disability evaluation
females
low back pain
pain assessment
Range of motion
Soft tissue
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2025-03-14
Enrollment: 40
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Non-specific Low Back Pain defined by tension, soreness, and/or stiffness of the lower back with unknown origins of pain. Reduction in hamstrings flexibility has found to be one of the causes for development of low back pain. Soft tissue manipulation can help loosen these muscles up and decrease a lot of the pain an individual may be having. Two specific kinds of soft tissue techniques will be utilized in this study are Graston Technique and Active Release Technique. So the aim of this project is to compare the effects of Graston Technique (GT) and Active Release Technique (ART) in the females with NSLBP. The study will be a randomized clinical trial and will be conducted in Allama Iqbal Memorial Teaching Hospital Sialkot. Non-probability convenience sampling technique will be used and participants will be recruited in groups after randomization. The subjects (n=40) will be divided into two groups. First group will include 20 women and graston technique will be applied. Group B will include 20 women and receive active release technique. Both the Groups will receive Hot Pack for 10 minutes, Passive stretching and Therapeutic Exercises for core stability; will be performed 2 times a week with 10 second hold of each exercise. Outcome measures will be taken using Numeric pain rating scale (NPRS) for pain, Universal Goniometer (GU) for Active knee extension test and popliteal angle measurement and Oswestry Disability Index for disability in the female patients with NSLBP. Outcome measures will be measured at baseline and after 4 weeks. Data analysis will be done by SPSS version 25.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Numeric Pain Rating Scale
timeFrame: 4 weeks
measure: Oswestry Disability Index
timeFrame: 4 weeks
measure: Universal Goniometer (UG)
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sialkot
country: Pakistan
facility: Allama Iqbal Memorial Teaching Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Ghulam Fatima, PHD*
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.