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Comparison Between the Segmental Mobilization and Entire Segmental Spine Mobilization in Cervical Spondylosis

Primary Purpose

Cervical Spondylosis

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Segmental Mobilization
Entire Spine Mobilization
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Spondylosis

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Yusra General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Segmental Mobilization

Entire Spine Mobilization

Arm Description

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

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

Outcomes

Primary Outcome Measures

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%
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 .
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.

Secondary Outcome Measures

Full Information

First Posted
February 25, 2020
Last Updated
February 27, 2020
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04287634
Brief Title
Comparison Between the Segmental Mobilization and Entire Segmental Spine Mobilization in Cervical Spondylosis
Official Title
Comparison Between the Segmental Mobilization and Entire Segmental Spine Mobilization in Cervical Spondylosis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
July 14, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Cervical spondylosis which is the common age related process having disturbing one or multiple segments of cervical spine. Cervical spondylosis shows a series of changes that is degenerative changes of discs and facet joints including bony growths of bodies of vertebrae, hypertrophy of arches of lamina and facet joints and instability of various segments in cervical spine. Origin of any degenerative disorders is linked with aging process. Cervical spondylosis worsens with age.As the age increases the cartilages and bones that make up our spine gradually develop wear and tear these changes can include dehydrated discs, herniated discs, bony spurs and causes neck injuries. Mechanical neck disorders will great react to conservative management, but the gold standard intervention for the mechanical neck pain has yet to be recognized. There are many interventions which have Some treatments have been review in various randomized control studies (RCT), but I will show the best accessible evidence for the mostly common used ones. Conservative management of the neck pain is respond well .On daily activities postural awareness and stress management strategies, work place (ergonomics) or hobbies may be valuable in many patients. Patient reeducation is necessary and advised to patient to use merely one pillow at night and When the intensity of pain is high, anti- inflammatory agents or analgesics are broadly and commonly used. Tricycle antidepressants having low dose for example amitriptyline( 10-30 mg) each night, may produce better results .Yoga ,Alexander techniques and pilates exercises are essential for improving posture of neck but the cost of these interventions in treating pain in neck is tentative. Randomized controlled studies (RCT) which is included in meta analysis of Manual therapy interventions therapy (Manipulation or mobilization physiotherapy ) provide inadequate evidence that mobilization techniques and manipulation are more valuable for the treatment of the severe neck pain as compared to the active treatments (patient reeducation, counseling, drug therapy ). However, manipulation as compared to mobilization has been linked with severe neurological complications and damages round about 5-10 per 10 million manipulations. Manipulation (high velocity amplitude thrust ), Mobilization or therapeutic exercises appear to be equally successful . A study which evaluate manipulation with therapeutic exercise whether modality separately used proved the combination to be more valuable for three months but there is no significant difference was notice than the exercises therapy only from one to two years . However, one more study showed no significant advantage for six weeks and six months by additional interventions manual therapy techniques, mobilization physiotherapy of 63% of population or shortwave diathermy(SWD) along with exercise and advice. Meta analysis of various frail randomized controlled trials and studies showed no strong evidence about the value ability and usefulness of both manual and mechanical traction and acupuncture with a range of other treatments in patients with chronic pain in neck. Further additional interventions techniques like psychotherapy for example cognitive behavioral therapy also cause extra and additional effects to mechanical and physical intervention alone. Many studies and systemic reviews are required to evaluate the effectiveness and usefulness of standardized interventions in patients of cervical spondylosis. Due to finding the long term effects the lengthy follow up of interventions , large sample size ,lack of regularity in study designs and using multiple set up across the studies are complicated. Analyses will also be tough because of the use of more than one intervention strategies in same study design.Strong evidences are required to identify the cost effectiveness of intervention strategies. A study on identify the effects of central and unilateral posterior anterior (UPA) mobilization technique on cervical spine lordosis, stiffness of muscles and range of motion in cervical spondylosis .There were significant Improvement in Cervical lordosis .however Muscle stiffness was significantly reduce after intervention and the effect of treatment lasted for five days without any supplementary intervention. The angles of cervical flexion and cervical extension angles were greater than before. Both the angles of lateral flexion and left rotation were significantly better and the effects of treatment which is proceeding for five days without any extra intervention. These results suggests that central and UPA mobilization manual therapy techniques is more valuable and effective in increasing cervical lordosis and range of motion, and lessening of stiffness of muscles in patients having cervical spondylosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Spondylosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Segmental Mobilization
Arm Type
Experimental
Arm Description
Hot Fermentation Soft tissue mobilization + Targeted Segmental Mobilization Home plan exercise= cervical muscles stretching, postural care
Arm Title
Entire Spine Mobilization
Arm Type
Experimental
Arm Description
Hot fermentation Soft tissue mobilization + Entire spine mobilization Home plan exercises=cervical muscles stretches, postural care
Intervention Type
Other
Intervention Name(s)
Segmental Mobilization
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Entire Spine Mobilization
Intervention Description
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.
Primary Outcome Measure Information:
Title
Neck Disability Index
Description
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%
Time Frame
3 Week
Title
Numeric Pain Rating Scale (NPRS)
Description
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 .
Time Frame
3 Week
Title
Range of Motion (ROM) of cervical spine
Description
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.
Time Frame
3 Week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Symptoms of Cervical Spondylosis more than month Limited Cervical ROM (at least any 2 ROM) Exclusion Criteria: Positive Vertebrobasilar Insufficiency & Sharp Purser Test Spinal stenosis. Osteoporosis. Trauma. Spondylosis Inflammatory arthritis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdul Ghafoor Sajjad, Phd*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yusra General Hospital
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
46000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26755405
Citation
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.
Results Reference
background
PubMed Identifier
25420010
Citation
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.
Results Reference
background
PubMed Identifier
22851876
Citation
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.
Results Reference
background
PubMed Identifier
20205574
Citation
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.
Results Reference
background
PubMed Identifier
21891879
Citation
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.
Results Reference
background

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Comparison Between the Segmental Mobilization and Entire Segmental Spine Mobilization in Cervical Spondylosis

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