NCT06877767

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 14, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2025

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2025

Completed
Last Updated

March 24, 2025

Status Verified

March 1, 2025

Enrollment Period

8 months

First QC Date

March 10, 2025

Last Update Submit

March 19, 2025

Conditions

Keywords

disability evaluationfemaleslow back painpain assessmentRange of motionSoft tissue

Outcome Measures

Primary Outcomes (3)

  • Numeric Pain Rating Scale

    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.

    4 weeks

  • Oswestry Disability Index

    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.

    4 weeks

  • Universal Goniometer (UG)

    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 .

    4 weeks

Study Arms (2)

Group A: graston technique

EXPERIMENTAL

Group A: baseline physical therapy treatment along with graston technique

Other: Graston Technique

Group B: active release technique

ACTIVE COMPARATOR

Group B: baseline physical therapy treatment along with active release technique

Other: Active Release Technique

Interventions

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

Group A: graston 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.

Group B: active release technique

Eligibility Criteria

Age25 Years - 50 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Allama Iqbal Memorial Teaching Hospital

Sialkot, Punjab Province, Pakistan

RECRUITING

Related Publications (5)

  • 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.

    PMID: 36394725BACKGROUND
  • 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.

    PMID: 37949592BACKGROUND
  • 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.

    PMID: 31317831BACKGROUND
  • 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.

    PMID: 37330762BACKGROUND
  • 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.

    PMID: 28265144BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ghulam Fatima, PHD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Amjad, PHD*

CONTACT

Imran Amjad, PHD*

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2025

First Posted

March 14, 2025

Study Start

January 2, 2025

Primary Completion

September 2, 2025

Study Completion

September 15, 2025

Last Updated

March 24, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations