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NCT Number: NCT06877767

Graston Versus Active Release Technique in Females With Non Specific Low Back Pain

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.

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Key information

Age range

25 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Allama Iqbal Memorial Teaching Hospital

Sialkot, Punjab Province, Pakistan

Location status: Recruiting

Location contact

Aneesa Javaid, MS*

PRINCIPAL_INVESTIGATOR

Ghulam Fatima, PhD*

CONTACT

[email protected]

03034073057

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Graston Technique

Other

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 Release Technique

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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 .

Study contacts

Contact information is provided by the study sponsor or research team.

Imran Amjad, PHD*

CONTACT

[email protected]

03324390125

Imran Amjad, PHD*

CONTACT

[email protected]

0515481826

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of Graston Versus Active Release Technique on Hamstring Flexibility, Pain and Disability in Females With Non Specific Low Back Pain

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 14, 2025
Registry last updated
Mar 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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