NCT05393336

Brief Summary

The aim of this study is to compare the v-siting posture stabilization and clamshell exercises on pain and disability in patients with non-specific 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
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2022

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

First Submitted

Initial submission to the registry

May 23, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 26, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

May 26, 2022

Status Verified

May 1, 2022

Enrollment Period

7 months

First QC Date

May 23, 2022

Last Update Submit

May 23, 2022

Conditions

Non-specific Chronic Low Back Pain

Keywords

low back paindisabilitypain intensitychronic pain

Outcome Measures

Primary Outcomes (2)

  • NPRS for pain

    The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).

    6th week

  • RMQ for pain and disability

    The Roland-Morris Questionnaire (RMQ) is a self-administered disability measure in which greater levels of disability are reflected by higher numbers on a 24-point scale. For example, at the beginning of treatment, a patient's score was 12 and, at the conclusion of treatment, their score was 2 (10 points of improvement), we would calculate an 83% (10/12 x 100) improvement.

    6th week

Study Arms (2)

V-sitting posture stabilization

EXPERIMENTAL

V sitting exercises will be administered where patients will be asked to lift the torso and legs while engaging the core and abdominal muscles.

Other: V-sitting posture stabilization

modified clamshell exercises

EXPERIMENTAL

Participants will perform modified clamshell exercises monitored visually and using a stabilizer pressure biofeedback unit.

Other: Modified clamshell exercises

Interventions

V-sitting posture stabilizationOTHER

15 patients will be given a hot pack with TENS for 15 minutes. Followed by static stretching of the gluteus, hamstrings, and Iliopsoas muscles for 10 to 30 seconds hold and 2 to 4 repetitions. Then the patient will perform the V-sitting exercise for 10 seconds starting with 5 repetitions and progressing to 15 overtime. Each patient will receive treatment for 6 days per week and 6 weeks.

V-sitting posture stabilization
Modified clamshell exercisesOTHER

15 patients will be given a hot pack with TENS for 15 minutes. Followed by static stretching of the gluteus, hamstrings, and Iliopsoas muscles for 10 to 30 seconds hold and 2 to 4 repetitions. Then the patient will perform the modified clamshell exercise for 10 seconds starting with 5 repetitions and progressing to 15 overtime. Each patient will receive treatment for 6 days per week and 6 weeks.

modified clamshell exercises

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with non-specific low back pain for more than 3 months
  • Subjects being able to sustain 5 seconds of isometric hip abduction in the side-lying position
  • Negative Crossed Straight leg raise test
  • Negative Straight leg raise test

You may not qualify if:

  • Metabolic Bone disease (Osteoporosis)
  • Any History of Hip pathology
  • History of trauma
  • History of systemic disease (Rheumatologic disorders, spondylitis, spinal cord disease)
  • Radiculopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah Rehabilitation Clinic

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (9)

  • Kwok BC, Lim JXL, Kong PW. The Theoretical Framework of the Clinical Pilates Exercise Method in Managing Non-Specific Chronic Low Back Pain: A Narrative Review. Biology (Basel). 2021 Oct 25;10(11):1096. doi: 10.3390/biology10111096.

    PMID: 34827088BACKGROUND

  • Cho JH, Lee KH, Lim ST. Aged Lumbar Extension Strength of Chronic Low Back Pain in Korean Population of 10-80 Years. Iran J Public Health. 2020 Oct;49(10):1894-1901. doi: 10.18502/ijph.v49i10.4692.

    PMID: 33346210BACKGROUND

  • Popescu A, Lee H. Neck Pain and Lower Back Pain. Med Clin North Am. 2020 Mar;104(2):279-292. doi: 10.1016/j.mcna.2019.11.003. Epub 2019 Dec 20.

    PMID: 32035569BACKGROUND

  • Clark JR, Nijs J, Smart K, Holmes P, Yeowell G, Goodwin PC. Prevalence of Extreme Trait Sensory Profiles and Personality Types in Nonspecific Chronic Low Back Pain with Predominant Central Sensitization: Secondary Analysis of an International Observational Study. Pain Physician. 2019 May;22(3):E181-E190.

    PMID: 31151341BACKGROUND

  • Tanabe H, Akai M, Doi T, Arai S, Fujino K, Hayashi K; for Low back-pain Traction Therapy (LTT) Study. Immediate effect of mechanical lumbar traction in patients with chronic low back pain: A crossover, repeated measures, randomized controlled trial. J Orthop Sci. 2021 Nov;26(6):953-961. doi: 10.1016/j.jos.2020.09.018. Epub 2021 Mar 27.

    PMID: 33785233BACKGROUND

  • van Dillen LR, Lanier VM, Steger-May K, Wallendorf M, Norton BJ, Civello JM, Czuppon SL, Francois SJ, Roles K, Lang CE. Effect of Motor Skill Training in Functional Activities vs Strength and Flexibility Exercise on Function in People With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA Neurol. 2021 Apr 1;78(4):385-395. doi: 10.1001/jamaneurol.2020.4821.

    PMID: 33369625BACKGROUND

  • Krause F, Niederer D, Banzer W, Vogt L. Medical exercise and physiotherapy modes and frequency as predictors for a recurrence of chronic non-specific low back pain. J Back Musculoskelet Rehabil. 2021;34(4):665-670. doi: 10.3233/BMR-200149.

    PMID: 33749637BACKGROUND

  • 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

  • Sanchis-Sanchez E, Lluch-Girbes E, Guillart-Castells P, Georgieva S, Garcia-Molina P, Blasco JM. Effectiveness of mechanical diagnosis and therapy in patients with non-specific chronic low back pain: a literature review with meta-analysis. Braz J Phys Ther. 2021 Mar-Apr;25(2):117-134. doi: 10.1016/j.bjpt.2020.07.007. Epub 2020 Aug 4.

    PMID: 32773288BACKGROUND

MeSH Terms

Conditions

Low Back PainPainChronic Pain

Condition Hierarchy (Ancestors)

Back PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Muhammad Salman Bashir, PhD

    Riphah International University

    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
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2022

First Posted

May 26, 2022

Study Start

June 1, 2022

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

May 26, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)