NCT05915715

Brief Summary

Non-specific chronic low back pain (NS-CLBP) is defined as lumber pain persisting for longer than three months, in absence of a suspected pathology or any specific cause. A specific diagnosis of low back pain cannot be obtained in approximately 80% patients with low back pain, indicating that patients with low back pain are often diagnosed with non-specific low back pain and these are the majority of the individuals with low back pain that present to physiotherapy In other cases the cause may be a minor problem with a disc between two spinal bones (vertebrae), or a minor problem with a small facet joint between two vertebrae. There may be other minor problems in the structures and tissues of the lower back that result in pain. Objective of this study is to compare the effects McGill stabilization exercises and proprioceptive neuromuscular facilitation technique on pain, range of motion and functional disability in chronic non-specific Low back pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

March 3, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 14, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 23, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2023

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2023

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

7 months

First QC Date

June 14, 2023

Last Update Submit

November 10, 2023

Conditions

Keywords

Non-specific Low back pain, McGill, Paraspinal muscles

Outcome Measures

Primary Outcomes (3)

  • 1. Numerical Rating Scale (NPRS)

    Numeric Rating Scale (NPRS) is most frequently used instruments to measure pain intensity in neck pain .The 11-point numeric with 0 representing No pain, 1-3 representing Mild Pain (nagging, annoying, interfering little with ADLs), 4-6 representing Moderate Pains (interferes significantly with ADLs), 7-10 representing Sever Pain (disabling, unable to perform ADLs)

    [Time Frame: 6th week]

  • 2. Bubble Inclinometer

    The spinous process of the 1st sacral vertebra and the 12th thoracic vertebra were considered as reference points for measuring the range of motion in bending forward and backward. The spinous process of the 12th thoracic vertebra was considered as reference point for measuring the range of motion of lumbar side flexion. Two bubble inclinometers were used simultaneously for measuring the lumbar range of motion when bending forward (in the standing position), and one bubble inclinometer for measuring the lumbar range of motion for back extension (in the standing) and side flexion (in the standing position).The actual ranges of motion of lumbar area when bending forward and backward were calculated by subtracting the number (degree) obtained by the lower inclinometer from the number (degree) obtained by the upper inclinometer

    [Time Frame: 6th week]

  • 3. Modified Oswestery Disability Index (MODI)

    For patients with low back pain, the Oswestry Disability Index (ODI) is a well-recognized and widely used patient reported health questionnaire and outcome measure. It is a self-rating questionnaire comprised of a series of ten sections, each with six statements describing functional impairment in a variety of activities of daily living including: personal care, lifting, sitting, standing, walking, sleeping, sex life, social life and travelling, as well as the intensity of pain and its response to analgesia. The six statements are scored from 0-5 and responses are added to give a total score out of a maximum possible score of 50 (or 45 if the question on sex life is omitted). This score can subsequently be categorized in to five levels of increasing disability

    [Time Frame: 6th week]

Secondary Outcomes (4)

  • ROM lumber spine (flexion)

    [Time Frame: 6th week]

  • ROM lumber spine (side flexion)

    [Time Frame: 6th week]

  • ROM lumber spine (extension)

    [Time Frame: 6th week]

  • ROM lumber spine (rotation)

    [Time Frame: 6th week]

Study Arms (2)

McGill stabilization exercise

EXPERIMENTAL

The patients performed the corresponding exercises 3 days a week and 10 repetitions of each exercise for a period of 6 weeks and a rest interval of 2 minutes between exercises

Other: McGill stabilization exercise

Proprioceptive neuromuscular facilitation technique

EXPERIMENTAL

The total duration of RS will be of approximately 33 minutes

Other: Proprioceptive neuromuscular facilitation technique

Interventions

McGill Curl Up Lie down on your back. The Side Bridge Lie on your side. The Bird Dog.

McGill stabilization exercise

. The patient is in sitting position and faces the physical therapist. The RST program consisted of alternating (trunk flexion-extension) isometric contractions against resistance for 10 seconds, with no motion intended. Subjects performed 3 sets of 15 repetitions at maximal resistance provided by the same physical therapist. Rest intervals of 30 seconds and 60 seconds were provided after the completion of 15 repetitions for each pattern and between sets, respectively.

Proprioceptive neuromuscular facilitation technique

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • years
  • Both Genders.
  • Mild to moderate back pain with NPRS pain score of between 2/10- 6/10.
  • Chronic low back pain for more than 3 months.
  • No radiating pain below the gluteal fold.

You may not qualify if:

  • Diagnosed with disc herniation
  • lumber canal stenosis
  • spondylolysis,
  • Lumbar radiculopathy
  • Lumbar vertebral fracture
  • Any referred pain below gluteal fold or neurological involvement in lower limbs
  • Participants who had undergone surgery for lumbopelvic surgery, abdominal, shoulder and lower limb surgery.
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (7)

  • Fouda KZ, Dewir IM, Abdelsalam MS. Effects of proprioceptive neuromuscular facilitation techniques in treating chronic nonspecific low back pain patients. Physiotherapy Quarterly. 2021;29(2):32-7.

    BACKGROUND
  • Gianola S, Bargeri S, Del Castillo G, Corbetta D, Turolla A, Andreano A, Moja L, Castellini G. Effectiveness of treatments for acute and subacute mechanical non-specific low back pain: a systematic review with network meta-analysis. Br J Sports Med. 2022 Jan;56(1):41-50. doi: 10.1136/bjsports-2020-103596. Epub 2021 Apr 13.

    PMID: 33849907BACKGROUND
  • Dal Farra F, Risio RG, Vismara L, Bergna A. Effectiveness of osteopathic interventions in chronic non-specific low back pain: A systematic review and meta-analysis. Complement Ther Med. 2021 Jan;56:102616. doi: 10.1016/j.ctim.2020.102616. Epub 2020 Nov 13.

    PMID: 33197571BACKGROUND
  • Suh JH, Kim H, Jung GP, Ko JY, Ryu JS. The effect of lumbar stabilization and walking exercises on chronic low back pain: A randomized controlled trial. Medicine (Baltimore). 2019 Jun;98(26):e16173. doi: 10.1097/MD.0000000000016173.

    PMID: 31261549BACKGROUND
  • Russo M, Deckers K, Eldabe S, Kiesel K, Gilligan C, Vieceli J, Crosby P. Muscle Control and Non-specific Chronic Low Back Pain. Neuromodulation. 2018 Jan;21(1):1-9. doi: 10.1111/ner.12738. Epub 2017 Dec 12.

    PMID: 29230905BACKGROUND
  • Garcia-Martinez E, Soler-Gonzalez J, Blanco-Blanco J, Rubi-Carnacea F, Masbernat-Almenara M, Valenzuela-Pascual F. Misbeliefs about non-specific low back pain and attitudes towards treatment by primary care providers in Spain: a qualitative study. BMC Prim Care. 2022 Jan 14;23(1):9. doi: 10.1186/s12875-021-01617-3.

    PMID: 35172719BACKGROUND
  • Chang JR, Wang X, Lin G, Samartzis D, Pinto SM, Wong AYL. Are Changes in Sleep Quality/Quantity or Baseline Sleep Parameters Related to Changes in Clinical Outcomes in Patients With Nonspecific Chronic Low Back Pain?: A Systematic Review. Clin J Pain. 2021 Dec 22;38(4):292-307. doi: 10.1097/AJP.0000000000001008.

    PMID: 34939973BACKGROUND

Study Officials

  • Sana Hafeez, PhD*

    Riphah International University Lahore Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2023

First Posted

June 23, 2023

Study Start

March 3, 2023

Primary Completion

September 28, 2023

Study Completion

October 2, 2023

Last Updated

November 13, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations