NCT04287634

Brief Summary

All the patients of cervical spondylosis which were enrolled in this study were assessed in Rehabilitation centre of Yusra General Hospital. Patients who compete the inclusion criteria are randomly assigned by the seal envelop method in to two groups interventional and control group. There is nine sessions of three weeks rehabilitation program and Pain is assessed on Numeric pain rating scale, Disability on Neck Disability index and ROM is assessed by Goniometer in 1ST, 4TH and last visit. Three sessions of intervention is given to patient per week.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 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

March 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 14, 2018

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 27, 2020

Completed
Last Updated

March 2, 2020

Status Verified

February 1, 2020

Enrollment Period

4 months

First QC Date

February 25, 2020

Last Update Submit

February 27, 2020

Conditions

Cervical Spondylosis

Outcome Measures

Primary Outcomes (3)

  • Neck Disability Index

    Neck Disability Index is the patient completed, specific condition related functional questionnaire with scoring 10 item that is pain, lifting, personal care, headaches, driving, concentration , recreation, work, reading and sleeping. Neck Disability Index can be used for musculoskeletal neck pain having chronic (more than 3 months), whiplash linked disorders and cervical radiculopathy. The neck disability index is translated in various languages having its own reliability and validity. In every 10 items scores, Activities of daily living (ADLs) are linked to 7 scores, 2 scores are associated to pain and 1 score are correlated to concentration. The scores from every item ranges from 0 to 5 and the final score is reported in percentage with total likely score is 100%

    3 Week

  • Numeric Pain Rating Scale (NPRS)

    NPRS numeric scale ranges from 0 to 10 in which no pain is shows by 0 point and worst pain is showed by 10 point, the pain explain as worst as you can .

    3 Week

  • Range of Motion (ROM) of cervical spine

    Changes from the Baseline, Goniometer was used to measure Cervical Range of motion. For determine ROM of cervical spine, the patients were ask to sit straight with their thoracic area supported with a back of a chair. Patient's feet were placed horizontally on the floor with knees and hips at right angle to each other and arms were folded over the chest to reduce movement in the thoracic region. The patients were asked to move the head as far as possible in a standard manner. All the ranges of cervical spine that is flexion, extension, right and left side bending, and right and left side rotation is measured.

    3 Week

Study Arms (2)

Segmental Mobilization

EXPERIMENTAL

Hot Fermentation Soft tissue mobilization + Targeted Segmental Mobilization Home plan exercise= cervical muscles stretching, postural care

Other: Segmental Mobilization

Entire Spine Mobilization

EXPERIMENTAL

Hot fermentation Soft tissue mobilization + Entire spine mobilization Home plan exercises=cervical muscles stretches, postural care

Other: Entire Spine Mobilization

Interventions

Segmental MobilizationOTHER

Hot fermentation =10 minutes Soft tissue mobilization =5 minutes Targeted segmental mobilization= 3 sets of 10 repetitions Home plan exercise= cervical muscles stretching, postural care.

Segmental Mobilization
Entire Spine MobilizationOTHER

Hot fermentation=10 minutes Soft tissue mobilization=5 minutes Entire spine mobilization =3 sets of 10 repetitions Home plan exercises=cervical muscles stretches, postural care.

Entire Spine Mobilization

Eligibility Criteria

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

You may qualify if:

  • Symptoms of Cervical Spondylosis more than month
  • Limited Cervical ROM (at least any 2 ROM)

You may not qualify if:

  • Positive Vertebrobasilar Insufficiency \& Sharp Purser Test
  • Spinal stenosis.
  • Osteoporosis.
  • Trauma.
  • Spondylosis
  • Inflammatory arthritis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yusra General Hospital

Rawalpindi, Punjab Province, 46000, Pakistan

Location

Related Publications (5)

  • Celenay ST, Akbayrak T, Kaya DO. A Comparison of the Effects of Stabilization Exercises Plus Manual Therapy to Those of Stabilization Exercises Alone in Patients With Nonspecific Mechanical Neck Pain: A Randomized Clinical Trial. J Orthop Sports Phys Ther. 2016 Feb;46(2):44-55. doi: 10.2519/jospt.2016.5979. Epub 2016 Jan 11.

    PMID: 26755405BACKGROUND

  • Langevin P, Desmeules F, Lamothe M, Robitaille S, Roy JS. Comparison of 2 manual therapy and exercise protocols for cervical radiculopathy: a randomized clinical trial evaluating short-term effects. J Orthop Sports Phys Ther. 2015 Jan;45(1):4-17. doi: 10.2519/jospt.2015.5211.

    PMID: 25420010BACKGROUND

  • Boyles R, Toy P, Mellon J Jr, Hayes M, Hammer B. Effectiveness of manual physical therapy in the treatment of cervical radiculopathy: a systematic review. J Man Manip Ther. 2011 Aug;19(3):135-42. doi: 10.1179/2042618611Y.0000000011.

    PMID: 22851876BACKGROUND

  • Kanlayanaphotporn R, Chiradejnant A, Vachalathiti R. Immediate effects of the central posteroanterior mobilization technique on pain and range of motion in patients with mechanical neck pain. Disabil Rehabil. 2010;32(8):622-8. doi: 10.3109/09638280903204716.

    PMID: 20205574BACKGROUND

  • Forbush SW, Cox T, Wilson E. Treatment of patients with degenerative cervical radiculopathy using a multimodal conservative approach in a geriatric population: a case series. J Orthop Sports Phys Ther. 2011 Oct;41(10):723-33. doi: 10.2519/jospt.2011.3592. Epub 2011 Sep 4.

    PMID: 21891879BACKGROUND

MeSH Terms

Conditions

Spondylosis

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Abdul Ghafoor Sajjad, Phd*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2020

First Posted

February 27, 2020

Study Start

March 1, 2018

Primary Completion

June 30, 2018

Study Completion

July 14, 2018

Last Updated

March 2, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)