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Clinical Trials/CTRI/2019/05/018916
CTRI/2019/05/018916CompletedNot Applicable

Effect of incorporating diaphragmatic breathing exercises with core stabilization exercises on pain, disability and sleep in chronic low back pain.

Jamia Millia Islamia1 site in 1 country22 target enrollmentStarted: June 5, 2019Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
22
Locations
1
Primary Endpoint
pain, disability and sleep

Study Overview

Brief Summary

**Objective of the study:**Tocompare the effect of combining diaphragmatic breathing with core stabilizationexercise in patients with chronic low back in pain, disability, and sleep.

**Significance of the study:**CLBPis a common problem in adults. Current recommendation for treating the patientwith CLBP is core stabilization exercises. The core stabilization exerciseswere found effective in many studies in reducing pain and disability. Currentlythere is no evidence of improving the symptoms by incorporating thediaphragmatic breathing exercise with core stabilization exercise which is oneof the important core muscle. The pain and disability was found improved withcore stabilization exercise but it is not reported that the sleep quality wereimproved or not. Therefore, this study evaluates the effect of corestabilization exercises with diaphragmatic breathing exercise on sleep quality,pain and disability on individual with CLBP. Clinically the result of thisstudy one can apply to improve the patient’s pain disability and sleep.

Method:  Total of 22 sample of (1=experimentalgroup, 11=control group) will be taken from Jamia Millia Islamia, New Delhi,India based on the inclusion exclusion criteria.

**Research design:**Twogroup comparative pretest-posttest design, with random allocation into groups.

**Procedure:**CLBPsubjects will be recruited based upon the inclusion; exclusion criteria and subjectswill be informed about the study. All the subjects will be explained about thepurpose and possible risks of the study. They will be requested to sign theinformed consent which will explain about their rights as research subjects. Pre-testwill be done on the transverse abdominus activation, FABQ, NPRS, ODI, chestexpansion and PSQI parameters. The subjects will be randomly allocated intoexperimental and control group by chit method. Experimental group shall receivecore training exercise with diaphragmatic breathing exercise and control grouponly incorporate with core training. After four weeks of intervention, both thegroup will reassess on the transverse abdominus activation, FABQ, NPRS, ODI,chest expansion and PSQI parameters.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
Not Applicable

Eligibility Criteria

Ages
20.00 Year(s) to 60.00 Year(s) (—)

Inclusion Criteria

  • INCLUSION CRITERIA
  • Low back pain more than 3 month
  • Patients willing and able to participate in an exercise program safely and without cognitive impairments that would limit their participation.
  • Age: 20-60 years
  • Pain: 2 to 7 on NPRS
  • Gender: male and female
  • Working knowledge of English.

Exclusion Criteria

  • EXCLUSION CRITERIA
  • Any other limiting condition which would make diaphragmatic breathing contraindicating
  • Any other neurological disorder, underlying respiratory pathology
  • History of surgery in past year
  • History of injury in preceding 3 months
  • Spinal surgery
  • Osteoporosis
  • Subjects on sleep medication which affect sleep directly
  • Pregnancy
  • Diagnosed cardiovascular disease
  • Orthopedics problem limiting physical activity
  • Those already doing intensive physical activity >2h/week.

Outcomes

Primary Outcomes

pain, disability and sleep

Time Frame: 4 weeks

Secondary Outcomes

  • Electromyography, chest expansionand fear avoidance belief questionnaire(4 weeks)

Investigators

Sponsor Class
Other [central university]

Study Sites (1)

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