NCT05280977

Brief Summary

Study Design: Randomized Controlled Trial treatment techniques: post isometric relaxation and post facilitation stretching technique sample size: 35 in each group single blinded Before giving either treatment to each group, baseline data will be collected from each participant and then after 4th week of treatment.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

November 3, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 15, 2022

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2022

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 11, 2022

Completed
Last Updated

March 15, 2022

Status Verified

March 1, 2022

Enrollment Period

5 months

First QC Date

March 5, 2022

Last Update Submit

March 5, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • goniometer

    Range of motion will be measured by using universal standard goniometer.The goniometer comprises a body (rotation axis) with two arms attached to it, one being fixed and the other movable. The measurement of the ROM is performed by direct reading of the angle between the axis of rotation at the end of the active ROM of the movement assessed.

    4 WEEKS

Secondary Outcomes (1)

  • visual analog scale

    4 WEEKS

Other Outcomes (1)

  • Oswestry Low Back Pain Disability Questionnaire

    4 WEEKS

Study Arms (2)

POST ISOMETRIC RELAXATION

EXPERIMENTAL
Other: POST ISOMETRIC RELAXATION

POST FACILITATION STRETCHING

EXPERIMENTAL
Other: POST FACILITATION STRETCHING

Interventions

Group A (Post Isometric Relaxation + Conventional Physiotherapy): This group will receive Muscle Energy Technique in addition to conventional physiotherapy for the treatment of erector spinae tightness. The treatment will be given on alternate days for four weeks with 8 - 10 repetitions of METs per session.

POST ISOMETRIC RELAXATION

Group B (Post Facilitation Stretching + Conventional Physiotherapy): This group will receive Post Facilitation Stretching Technique in addition to conventional physiotherapy for the treatment of erector spinae tightness. The treatment will be given on alternate days for four weeks with 8 - 10 repetitions of METs per session.

POST FACILITATION STRETCHING

Eligibility Criteria

Age30 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Pain in lower back for atleast 4 weeks but less than 1 year.
  • Pain relieved by rest.
  • Decreased flexion, extension and lateral flexion of lumbar spine.
  • Individuals having no signs of nerve root irritation (dermatomal pain and paresthesia) and nerve root compression (dermatomal sensory loss, myotomal weakness, loss of reflex)
  • Age group: 30 - 45 years
  • Both male and female

You may not qualify if:

  • Individuals having other lumbar pathologies like disc problems, ligamentous strains, sciatica etc
  • Individuals having any inflammation and malignancy.
  • Pregnancy
  • Individuals having recent trauma, fracture, or surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bahria International Hospital Lahore

Lahore, Punjab Province, 54590, Pakistan

RECRUITING

Related Publications (7)

  • Balague F, Mannion AF, Pellise F, Cedraschi C. Non-specific low back pain. Lancet. 2012 Feb 4;379(9814):482-91. doi: 10.1016/S0140-6736(11)60610-7. Epub 2011 Oct 6.

    PMID: 21982256BACKGROUND
  • Bogduk N. Functional anatomy of the spine. Handb Clin Neurol. 2016;136:675-88. doi: 10.1016/B978-0-444-53486-6.00032-6.

    PMID: 27430435BACKGROUND
  • Panjabi MM, Goel V, Oxland T, Takata K, Duranceau J, Krag M, Price M. Human lumbar vertebrae. Quantitative three-dimensional anatomy. Spine (Phila Pa 1976). 1992 Mar;17(3):299-306. doi: 10.1097/00007632-199203000-00010.

    PMID: 1566168BACKGROUND
  • Sung PS, Lammers AR, Danial P. Different parts of erector spinae muscle fatigability in subjects with and without low back pain. Spine J. 2009 Feb;9(2):115-20. doi: 10.1016/j.spinee.2007.11.011. Epub 2008 Feb 14.

    PMID: 18280212BACKGROUND
  • Friberg O. Clinical symptoms and biomechanics of lumbar spine and hip joint in leg length inequality. Spine (Phila Pa 1976). 1983 Sep;8(6):643-51. doi: 10.1097/00007632-198309000-00010.

    PMID: 6228021BACKGROUND
  • Allegri M, Montella S, Salici F, Valente A, Marchesini M, Compagnone C, Baciarello M, Manferdini ME, Fanelli G. Mechanisms of low back pain: a guide for diagnosis and therapy. F1000Res. 2016 Jun 28;5:F1000 Faculty Rev-1530. doi: 10.12688/f1000research.8105.2. eCollection 2016.

    PMID: 27408698BACKGROUND
  • Wilson E, Payton O, Donegan-Shoaf L, Dec K. Muscle energy technique in patients with acute low back pain: a pilot clinical trial. J Orthop Sports Phys Ther. 2003 Sep;33(9):502-12. doi: 10.2519/jospt.2003.33.9.502.

    PMID: 14524509BACKGROUND

Study Officials

  • SYEDA RAHAT JABEEN, MSPT

    University of Lahore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Haiderullah khan, MS PTN

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The study will be single blinded as the assessor will be unaware of the treatment that will be given to both groups.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2022

First Posted

March 15, 2022

Study Start

November 3, 2021

Primary Completion

April 2, 2022

Study Completion

April 11, 2022

Last Updated

March 15, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations