Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04287634
Other study ID # Kiran REC-00296
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2018
Est. completion date July 14, 2018

Study information

Verified date February 2020
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date July 14, 2018
Est. primary completion date June 30, 2018
Accepts healthy volunteers No
Gender All
Age group 30 Years to 60 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Segmental Mobilization
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.
Entire Spine Mobilization
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.

Locations

Country Name City State
Pakistan Yusra General Hospital Rawalpindi Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
See also
  Status Clinical Trial Phase
Completed NCT01243684 - A Magnetic Resonance Imaging Study of Patients With Cervical Spondylosis N/A
Completed NCT04955496 - ERAS on Cervical Surgery
Completed NCT04544683 - Effectiveness of Cervical Transforaminal Epidural Steroid Injection Phase 4
Completed NCT04039581 - KT® in Patients With Cervical Spine Surgery N/A
Recruiting NCT06130982 - Effects of Different Health Qigong Routines on CS Among Chinese College Students N/A
Completed NCT00788008 - Cognitive Effects of Inhalational Versus Intravenous General Anesthesia in the Elderly N/A
Recruiting NCT06351254 - Kinesthetic Exercises and Sine Sound Waves in Cervical Spondylosis N/A
Completed NCT05086367 - Effects of Breathing Exercises on Pain, Range of Motion and Neck Disability in Patients With Cervical Spondylosis N/A
Completed NCT04489394 - Quintex® Follow-up After One Year Minimum
Completed NCT04852393 - Ultrasound-guided Cervical Medial Branch Blocks
Enrolling by invitation NCT05066711 - NuVasive® ACP System Study
Recruiting NCT02819089 - Recovery Profiles After c Spine Surgery: With or Without Dexmedetomidine as an Anesthetic Adjuvant N/A
Withdrawn NCT01616719 - Evaluation of DTRAX Graft in Patients With Cervical Degenerative Disc Disease N/A
Completed NCT03425682 - ViBone in Cervical and Lumbar Spine Fusion
Completed NCT04777318 - Comparison of the Effects of Different Manual Therapy Techniques in Patients With Cervical Spondylosis N/A
Completed NCT05916794 - Comparative Effects of Modified Cervical Retraction and Motor Control Therapeutics Exercises in Cervical Spondylosis N/A
Terminated NCT02758899 - Diabetes and Glycosylation in Cervical Spondylosis
Terminated NCT02276911 - Safety and Efficacy of Pre-incisional Intravenous Ibuprofen to Reduce Postoperative Pain and Opioid Dependence After Posterior Cervical or Lumbar Instrumented Spine Surgery Phase 2
Recruiting NCT05920564 - Upper Trapezius Stretching in Patients With Cervical Spondylosis N/A
Recruiting NCT05910593 - Establishing the Validity and Reliability of a Dexterity Assessment Tool