NCT06240949

Brief Summary

The purpose of the study is to compare the effect of positional release technique and manual pressure technique of hip flexors on pain, range of motion, lumbosacral angle and disability in patients with chronic low back pain

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
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

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 5, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 26, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 5, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2024

Completed
Last Updated

February 5, 2024

Status Verified

January 1, 2024

Enrollment Period

3 months

First QC Date

December 26, 2023

Last Update Submit

January 28, 2024

Conditions

Chronic Low-back Pain

Keywords

Low back painChronic low back painHip flexorspositional release techniqueManual Pressure Technique

Outcome Measures

Primary Outcomes (4)

  • Hip flexors tightness

    Hip flexors tightness will be assessed using an inclinometer to measure the range of motion (ROM) for active hip extension and Lumbosacral angle

    4th week

  • Pain Intensity

    Pain intensity will be evaluated using the Numeric Pain Rating Scale (NPRS)

    4th week

  • Functional disability

    Functional disability will be assessed by Oswestry disability questionnaire.

    4th week

  • Anterior pelvic tilt

    Anterior pelvic tilt will be measured using an inclinometer

    4th week

Study Arms (2)

Positional release technique

EXPERIMENTAL

Positional release technique will be applied on iliopsoas muscle.

Device: Positional Release Technique

Manual pressure technique

EXPERIMENTAL

Manual pressure technique will be applied on iliopsoas muscle.

Device: Manual Pressure Technique

Interventions

Positional Release TechniqueDEVICE

Positional Release Technique will be applied on iliopsoas muscle. Treatment time will be 30 minutes per session, 4 times/week for 4 weeks in the hospital setting.

Positional release technique
Manual Pressure TechniqueDEVICE

Manual Pressure Technique will be applied on iliopsoas muscle. Treatment time will be 30 minutes per session, 4 times/week for 4 weeks in the hospital setting.

Manual pressure technique

Eligibility Criteria

Age25 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Males and females
  • age group 25 to 40yrs
  • Atraumatic chronic low back pain more than 3 months
  • Patients with Anterior pelvic tilt
  • Patients with lumbosacral angle \> than 50 degrees

You may not qualify if:

  • Pregnancy
  • history of vertebral fracture
  • History of any spinal surgery
  • Disc disease
  • Osteoporosis
  • Bone disease
  • Patient unable to give consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DHQ and tertiary hospitals

Khanewal, Pakistan

RECRUITING

Related Publications (15)

  • Juker D, McGill S, Kropf P, Steffen T. Quantitative intramuscular myoelectric activity of lumbar portions of psoas and the abdominal wall during a wide variety of tasks. Med Sci Sports Exerc. 1998 Feb;30(2):301-10. doi: 10.1097/00005768-199802000-00020.

    PMID: 9502361BACKGROUND

  • Avrahami D, Potvin JR. The clinical and biomechanical effects of fascial-muscular lengthening therapy on tight hip flexor patients with and without low back pain. J Can Chiropr Assoc. 2014 Dec;58(4):444-55.

    PMID: 25550670BACKGROUND

  • Aslan H, Buddhadev HH, Suprak DN, San Juan JG. ACUTE EFFECTS OF TWO HIP FLEXOR STRETCHING TECHNIQUES ON KNEE JOINT POSITION SENSE AND BALANCE. Int J Sports Phys Ther. 2018 Aug;13(5):846-859.

    PMID: 30276017BACKGROUND

  • Hoy D, Brooks P, Blyth F, Buchbinder R. The Epidemiology of low back pain. Best Pract Res Clin Rheumatol. 2010 Dec;24(6):769-81. doi: 10.1016/j.berh.2010.10.002.

    PMID: 21665125BACKGROUND

  • Naik Prashant P, Anand H, Khatri Subhash M. Comparison of muscle energy technique and positional release therapy in acute low back pain-RCT. Physiotherapy and Occupational Therapy. 2010;32

    BACKGROUND

  • Deyo RA, Von Korff M, Duhrkoop D. Opioids for low back pain. BMJ. 2015 Jan 5;350:g6380. doi: 10.1136/bmj.g6380.

    PMID: 25561513BACKGROUND

  • Gonzalez-Galvez N, Gea-Garcia GM, Marcos-Pardo PJ. Effects of exercise programs on kyphosis and lordosis angle: A systematic review and meta-analysis. PLoS One. 2019 Apr 29;14(4):e0216180. doi: 10.1371/journal.pone.0216180. eCollection 2019.

    PMID: 31034509BACKGROUND

  • Santaguida PL, McGill SM. The psoas major muscle: a three-dimensional geometric study. J Biomech. 1995 Mar;28(3):339-45. doi: 10.1016/0021-9290(94)00064-b.

    PMID: 7730392BACKGROUND

  • Licciardone JC, Kearns CM, Crow WT. Changes in biomechanical dysfunction and low back pain reduction with osteopathic manual treatment: results from the OSTEOPATHIC Trial. Man Ther. 2014 Aug;19(4):324-30. doi: 10.1016/j.math.2014.03.004. Epub 2014 Mar 18.

    PMID: 24704126BACKGROUND

  • Chaitow L. Positional Release Techniques E-Book: Elsevier health sciences; 2007

    BACKGROUND

  • Ibraheem EEMAE. Conventional therapy versus positional release technique in the treatment of chronic low back dysfunction. Int J Physiother Res. 2017;5(5):2325-31

    BACKGROUND

  • Hanson P, Magnusson SP, Simonsen EB. Differences in sacral angulation and lumbosacral curvature in black and white young men and women. Acta Anat (Basel). 1998;162(4):226-31. doi: 10.1159/000046437.

    PMID: 9831771BACKGROUND

  • Mosner EA, Bryan JM, Stull MA, Shippee R. A comparison of actual and apparent lumbar lordosis in black and white adult females. Spine (Phila Pa 1976). 1989 Mar;14(3):310-4. doi: 10.1097/00007632-198903000-00011.

    PMID: 2711246BACKGROUND

  • Naik MS, Shah DN. Prevalence of tightness in hip joint muscles in middle aged women engaging in prolonged desk job: Descriptive study. Age. 2022;43:6.077908

    BACKGROUND

  • AWATEF ML, ALI FAM, SHIMAA T, MAGDA GS. Effect of lumbar hyperlordosis correction on craniovertebral angle in low back pain patients. The Medical Journal of Cairo University. 2020;88(December):2051-7.

    BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Saba Rafique, phD

    Riphah International University, Lahore

    PRINCIPAL INVESTIGATOR

  • Faiza Alzaf

    Riphah International University, Lahore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Amjad, phD

CONTACT

03324390125imran.amjad@riphah.edu.pk

Study Design

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

Study Record Dates

First Submitted

December 26, 2023

First Posted

February 5, 2024

Study Start

November 5, 2023

Primary Completion

February 5, 2024

Study Completion

February 5, 2024

Last Updated

February 5, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)