NCT04082065

Brief Summary

the objective of the study was to determine the effect of Cyriax manipulation for Pain, range of motion and quality of life in lumbar internal derangement radiculopathy in single physical therapy session. Randomized control trails were carried out in Railway general hospital from February 2018 to July 2018 in which 43 patients with Low back pain were randomly divided by lottery method into control and experimental group. Single session of treatment was given. tools used in the study are visual analog scale, Oswestry disability index and lumber range of motion. data was analysed through SPSS (statistical package for social sciences) 21.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

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

January 15, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2018

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 5, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 9, 2019

Completed
Last Updated

September 13, 2019

Status Verified

September 1, 2019

Enrollment Period

5 months

First QC Date

September 5, 2019

Last Update Submit

September 12, 2019

Conditions

Keywords

Conventional physical therapy(CPT).Low back pain (LBP),Oswestery disability index (ODI),Quality of life (QOL),Range of motion (ROM)Visual analogue scale (VAS)

Outcome Measures

Primary Outcomes (1)

  • Owstery disability index

    ODI is self-reported tool used widely for measurement of functional disability related to. It was introduced by Fairbank et al in 1980 which gives guidelines for measuring functional disability due to LBP and considered gold standard. It is divided into 10 sections i.e. pain, personal care, sitting, walking, standing, travelling, weight lifting, sleeping, social life. Patient is guided to select one option according to their symptoms. Total score is 50.Once the individual score is calculated Percentage can be calculated by dividing it with total score i.e. 50 and then multiply it by 100.) In This study scores are calculated by filling the questionnaire before session and then filling it after two or three days after

    3rd day

Secondary Outcomes (5)

  • visual analog sclae

    1st day after session

  • range of motion lumber spine (flexion)

    1st day after session

  • range of motion lumber spine (extension)

    1st day after session

  • range of motion lumber spine (right side bending)

    1st day after session

  • range of motion lumber spine (left side bending)

    1st day after session

Study Arms (2)

conventional physical therapy

ACTIVE COMPARATOR

Myofacial release Stretching of hamstring and Piriformis

Other: conventional physical therapy

cyriax lumber manipulation group

EXPERIMENTAL

Myofacial Release stretching of hamstrings and Piriformis Cyriax Lumbar Manipulation Techniques

Other: cyriax lumber manipulation group

Interventions

hot pack for 15 minutes Myofacial release (10 minutes) and Stretching of hamstrings and Piriformis (5 reps each with 2 second hold)

conventional physical therapy

Hot Pack, Myofacial Release, stretching of hamstrings and Piriformis (five reps each with 2 seconds hold) and Cyriax Lumbar Manipulation Techniques

cyriax lumber manipulation group

Eligibility Criteria

Age30 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • lumber pain, pain radiating to leg, motor deficits in legs, , dural signs and symptoms, impaired nerve root mobility(straight leg raise and L3 stretch), back pain effecting Quality of life, ODI score less than 30 and Limited range of motion .

You may not qualify if:

  • Osteoporosis of hip, Bilateral sciatica, having anticoagulant medication, pregnancy, patient with impaired mental status

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International university

Islamabad, Federal, 44000, Pakistan

Location

Related Publications (14)

  • WHO Scientific Group on the Burden of Musculoskeletal Conditions at the Start of the New Millennium. The burden of musculoskeletal conditions at the start of the new millennium. World Health Organ Tech Rep Ser. 2003;919:i-x, 1-218, back cover.

    PMID: 14679827BACKGROUND
  • Katz JN. Lumbar disc disorders and low-back pain: socioeconomic factors and consequences. J Bone Joint Surg Am. 2006 Apr;88 Suppl 2:21-4. doi: 10.2106/JBJS.E.01273.

    PMID: 16595438BACKGROUND
  • Punnett L, Pruss-Utun A, Nelson DI, Fingerhut MA, Leigh J, Tak S, Phillips S. Estimating the global burden of low back pain attributable to combined occupational exposures. Am J Ind Med. 2005 Dec;48(6):459-69. doi: 10.1002/ajim.20232.

    PMID: 16299708BACKGROUND
  • Lidgren L. The bone and joint decade 2000-2010. Bull World Health Organ. 2003;81(9):629. Epub 2003 Nov 14. No abstract available.

    PMID: 14710501BACKGROUND
  • Dionne CE, Dunn KM, Croft PR. Does back pain prevalence really decrease with increasing age? A systematic review. Age Ageing. 2006 May;35(3):229-34. doi: 10.1093/ageing/afj055. Epub 2006 Mar 17.

    PMID: 16547119BACKGROUND
  • Ernst E, Canter PH. A systematic review of systematic reviews of spinal manipulation. J R Soc Med. 2006 Apr;99(4):192-6. doi: 10.1177/014107680609900418.

    PMID: 16574972BACKGROUND
  • Ombregt L. A System of Orthopaedic Medicine-E-Book: Elsevier Health Sciences; 2013.

    BACKGROUND
  • Rubinstein SM, Terwee CB, Assendelft WJ, de Boer MR, van Tulder MW. Spinal manipulative therapy for acute low back pain: an update of the cochrane review. Spine (Phila Pa 1976). 2013 Feb 1;38(3):E158-77. doi: 10.1097/BRS.0b013e31827dd89d.

    PMID: 23169072BACKGROUND
  • Assendelft WJ, Morton SC, Yu EI, Suttorp MJ, Shekelle PG. Spinal manipulative therapy for low back pain. A meta-analysis of effectiveness relative to other therapies. Ann Intern Med. 2003 Jun 3;138(11):871-81. doi: 10.7326/0003-4819-138-11-200306030-00008.

    PMID: 12779297BACKGROUND
  • Aure OF, Nilsen JH, Vasseljen O. Manual therapy and exercise therapy in patients with chronic low back pain: a randomized, controlled trial with 1-year follow-up. Spine (Phila Pa 1976). 2003 Mar 15;28(6):525-31; discussion 531-2. doi: 10.1097/01.BRS.0000049921.04200.A6.

    PMID: 12642755BACKGROUND
  • Wand BM, Bird C, McAuley JH, Dore CJ, MacDowell M, De Souza LH. Early intervention for the management of acute low back pain: a single-blind randomized controlled trial of biopsychosocial education, manual therapy, and exercise. Spine (Phila Pa 1976). 2004 Nov 1;29(21):2350-6. doi: 10.1097/01.brs.0000143619.34308.b4.

    PMID: 15507794BACKGROUND
  • McMorland G, Suter E, Casha S, du Plessis SJ, Hurlbert RJ. Manipulation or microdiskectomy for sciatica? A prospective randomized clinical study. J Manipulative Physiol Ther. 2010 Oct;33(8):576-84. doi: 10.1016/j.jmpt.2010.08.013.

    PMID: 21036279BACKGROUND
  • Muller R, Giles LG. Long-term follow-up of a randomized clinical trial assessing the efficacy of medication, acupuncture, and spinal manipulation for chronic mechanical spinal pain syndromes. J Manipulative Physiol Ther. 2005 Jan;28(1):3-11. doi: 10.1016/j.jmpt.2004.12.004.

    PMID: 15726029BACKGROUND
  • Bialosky JE, Bishop MD, Robinson ME, Zeppieri G Jr, George SZ. Spinal manipulative therapy has an immediate effect on thermal pain sensitivity in people with low back pain: a randomized controlled trial. Phys Ther. 2009 Dec;89(12):1292-303. doi: 10.2522/ptj.20090058. Epub 2009 Oct 1.

    PMID: 19797305BACKGROUND

MeSH Terms

Conditions

Low Back PainHypotension

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular Diseases

Study Officials

  • Abdul Ghafoor Sajjad, PHD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
single
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: interventional
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2019

First Posted

September 9, 2019

Study Start

January 15, 2018

Primary Completion

June 20, 2018

Study Completion

June 30, 2018

Last Updated

September 13, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations