NCT04044092

Brief Summary

The aim of this research is to find and compare the effect of conventional physical therapy and ELDOA stretching exercise on pain, range of motion and disability in patients with cervical disc protrusion. The Randomized controlled trials done at Armed Forces Institute of Rehabilitation Medicine, Rawalpindi. The sample size was 20. The subjects were divided in two groups, 10 subjects in conventional physical therapy group and 10 in ELDOA stretching exercise group. Study duration was of 6 months. Sampling technique applied was Convenient Sampling technique randomization in group through Lottery method (sealed envelope). Only 30-60 years individuals with cervical disc protrusion were included. Tools used in the study were measurement of ROM by bubble inclinometer, Numeric pain rating scale (NPRS) and neck disability index (NDI). Data was analyzed using SPSS 21.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

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, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2019

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 1, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2019

Completed
Last Updated

August 5, 2019

Status Verified

August 1, 2019

Enrollment Period

5 months

First QC Date

August 1, 2019

Last Update Submit

August 1, 2019

Conditions

Cervical Disc Herniation

Keywords

Cervical Disc ProtrusionELDOA,Neck PainNeck Disability

Outcome Measures

Primary Outcomes (8)

  • Neck disability index

    Changes from base line: Northwick disability index was developed first in Northwick Park hospital, England. It was designed to measure the neck pain and disability over time. It consists of 10, five parts sections. At the end, score is calculated by dividing the obtained score by total (50) multiplied by 100. As the driving section was missing in most of the female patients, total score was considered as 45 instead of 50.

    4th day

  • Numeric Pain rating scale (NPRS)

    Changes from base Line: Numeric Pain rating scale is a scale for pain starting from 0-10, where 0 indicate no pain and 10 indicate worst possible pain.

    4th day

  • ROM Cervical Spine (Flexion)

    Changes from the Baseline ROM: Range of Motion of Cervical spine flexion was taken with the help of bubble inclinometer

    4th day

  • ROM Cervical Spine (Extension)

    Changes from the Baseline ROM: Range of Motion of Cervical spine extension was taken with the help of bubble inclinometer

    4th day

  • ROM Cervical Spine (Right side flexion)

    Changes from the Baseline ROM: Range of Motion of Cervical spine right side flexion was taken with the help of bubble inclinometer

    4th day

  • ROM Cervical Spine (Left side Flexion)

    Changes from the Baseline ROM: Range of Motion of Cervical spine left side flexion was taken with the help of bubble inclinometer

    4th day

  • ROM Cervical Spine (Right rotation)

    Changes from the Baseline ROM: Range of Motion of Cervical spine right rotation was taken with the help of bubble inclinometer

    4th day

  • ROM Cervical Spine (Left rotation)

    Changes from the Baseline ROM: Range of Motion of Cervical spine left rotation was taken with the help of bubble inclinometer

    4th day

Study Arms (2)

Conservative physical therapy

ACTIVE COMPARATOR

Moist hot packs, TENS, Cervical Traction, Neural Mobilization, Cervical Spine strengthening exercises

Other: Conservative physical therapy

ELDOA stretching exercise

EXPERIMENTAL

ELDOA stretching exercise protocol along with Conservative physical therapy

Other: ELDOA stretching exercise

Interventions

Conservative physical therapyOTHER

Moist hot packs, TENS, Cervical Traction, Neural Mobilization on alternate days Cervical Spine strengthening exercises 10 repetitions×1 set, 4 days/week. Total of 4 sessions were given each consisting of 40 mins.

Conservative physical therapy
ELDOA stretching exerciseOTHER

Experimental group was given ELDOA stretching exercise protocol along with the moist hot packs, TENS, Cervical Traction, and Neural Mobilization on alternate days Cervical Spine strengthening exercises 10 repetitions×1 set, 4 days/week. Total of 4 sessions were given each consisting of 40 mins.

ELDOA stretching exercise

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • MRI with grading of disc protrusion
  • Radiculopathy
  • Limited ROM (measured by bubble Inclinometer)
  • Pain more than 3 on NPRS

You may not qualify if:

  • Malignancy,
  • Infection,
  • Trauma,
  • Bone deformities,
  • Severe osteoporosis
  • With marked bony and soft tissue disease
  • Taking other treatment in the same period of the research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Islamabad, 44000, Pakistan

Location

Related Publications (7)

  • Risbud MV, Shapiro IM. Role of cytokines in intervertebral disc degeneration: pain and disc content. Nat Rev Rheumatol. 2014 Jan;10(1):44-56. doi: 10.1038/nrrheum.2013.160. Epub 2013 Oct 29.

    PMID: 24166242BACKGROUND

  • Fejer R, Kyvik KO, Hartvigsen J. The prevalence of neck pain in the world population: a systematic critical review of the literature. Eur Spine J. 2006 Jun;15(6):834-48. doi: 10.1007/s00586-004-0864-4. Epub 2005 Jul 6.

    PMID: 15999284BACKGROUND

  • Schoenfeld AJ, George AA, Bader JO, Caram PM Jr. Incidence and epidemiology of cervical radiculopathy in the United States military: 2000 to 2009. J Spinal Disord Tech. 2012 Feb;25(1):17-22. doi: 10.1097/BSD.0b013e31820d77ea.

    PMID: 21430568BACKGROUND

  • Gross AR, Hoving JL, Haines TA, Goldsmith CH, Kay T, Aker P, Bronfort G; Cervical Overview Group. A Cochrane review of manipulation and mobilization for mechanical neck disorders. Spine (Phila Pa 1976). 2004 Jul 15;29(14):1541-8. doi: 10.1097/01.brs.0000131218.35875.ed.

    PMID: 15247576BACKGROUND

  • Bronfort G, Haas M, Evans RL, Bouter LM. Efficacy of spinal manipulation and mobilization for low back pain and neck pain: a systematic review and best evidence synthesis. Spine J. 2004 May-Jun;4(3):335-56. doi: 10.1016/j.spinee.2003.06.002.

    PMID: 15125860BACKGROUND

  • Hammer WI. Functional soft-tissue examination and treatment by manual methods: Jones & Bartlett Learning; 2007. 689-690

    BACKGROUND

  • Sajjad AG KA. Fascia Stretching Improve the Pain and Functional Level in Disc Protrusion Patients: Journal of Riphah College of Rehabilitation Sciences; 2016.

    BACKGROUND

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

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

Study Record Dates

First Submitted

August 1, 2019

First Posted

August 5, 2019

Study Start

January 15, 2019

Primary Completion

June 20, 2019

Study Completion

June 30, 2019

Last Updated

August 5, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)