V-sitting Posture Stabilization Versus Modified Clamshell in Patients With Non-specific Chronic Low Back Pain.

Non-specific Chronic Low Back Pain Clinical Trial

Official title:

Comparison of V-sitting Posture Stabilization and Modified Clamshell Exercises on Pain and Disability in Patients With Non-specific Chronic Low Back Pain.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05393336
• Other study ID #: REC/RCR & AHS/22/0104
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: January 1, 2023

Study information

• Verified date: May 2022
• Source: Riphah International University
• Contact: Imran Amjad, PhD
• Phone: 03324390125
• Email: imran.amjad[@]riphah.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Chronic low back pain (LBP) is a common musculoskeletal pain disorder that affects most adults and has the highest prevalence among other chronic musculoskeletal pain disorders. Non-traumatic lower back pain can have different etiologies: intervertebral disc related, vertebral body related, and facet joint related and sacroiliac joint related. Non-specific low back pain affects people of all ages and is a leading contributor to disease burden worldwide. Non-specific low back pain does not have a known pathoanatomical cause. Treatment of non-specific chronic low back pain includes manual therapy, exercise therapy, massage, acupuncture, yoga, cognitive behavioral therapy, and intensive interdisciplinary treatment.

Previous studies have compared the effects of different exercise therapies, other treatment modalities, osteopathic techniques, manual therapies, and yoga and eurhythmy therapy for the management of low back pain. There is very little literature found to evaluate the effects of single movement technique V-sitting exercises and modified clamshell exercises in the management of non-specific chronic low back pain. Previous literature showed less treatment sessions and follow up periods as they are barrier to see the exact picture of effects of treatment protocol followed. In contrast longer duration of treatment regime allow deep insight of the effects of the main treatment body. This study will fulfill these literature gaps. This study will find the comparative effects of V-sitting posture stabilization and Modified Clamshell exercises in the treatment of non-specific chronic low back pain with more treatment sessions in both genders.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Metabolic Bone disease (Osteoporosis)

• Any History of Hip pathology

• History of trauma

• History of systemic disease (Rheumatologic disorders, spondylitis, spinal cord disease)

• Radiculopathy

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Non-specific Chronic Low Back Pain

Intervention

Other:
• V-sitting posture stabilization
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.
• Modified clamshell exercises
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.

Locations

Country	Name	City	State
Pakistan	Riphah Rehabilitation Clinic	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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). pii: 1096. doi: 10.3390/biology10111096. Review. — View Citation

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. Review. — View Citation

Sanchis-Sánchez E, Lluch-Girbés E, Guillart-Castells P, Georgieva S, García-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. Review. — View Citation

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. — View Citation

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. Erratum in: JAMA Neurol. 2021 Jan 19;:. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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