Cervical SpondylosisNCT04287634
Comparison Between the Segmental Mobilization and Entire Segmental Spine Mobilization in Cervical Spondylosis
A study testing Segmental Mobilization and Entire Spine Mobilization in people with Cervical Spondylosis, run by Riphah International University at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Cervical Spondylosis
- What is being tested?
- Segmental Mobilization and Entire Spine Mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2018to 14 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Symptoms of Cervical Spondylosis more than month
- Limited Cervical ROM (at least any 2 ROM)
Who cannot join
- Positive Vertebrobasilar Insufficiency \& Sharp Purser Test
- Spinal stenosis.
- Osteoporosis.
- Trauma.
- Spondylosis
- Inflammatory arthritis.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Cervical Spondylosis
- Being tested
- Segmental Mobilization, Entire Spine Mobilization
- Medical subject headings
- Spondylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Segmental Mobilization | Experimental | Hot Fermentation Soft tissue mobilization + Targeted Segmental Mobilization Home plan exercise= cervical muscles stretching, postural care Receives: Other: Segmental Mobilization |
| Entire Spine Mobilization | Experimental | Hot fermentation Soft tissue mobilization + Entire spine mobilization Home plan exercises=cervical muscles stretches, postural care Receives: Other: Entire Spine Mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: 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 .
Measured: 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.
Measured: 3 Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study start1 Mar 2018
- Primary completion30 Jun 2018
- Study completion14 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cervical SpondylosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abdul Ghafoor Sajjad, Phd*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04287634
- Sponsor's protocol ID
- Kiran REC-00296
- Status last verified
- Feb 2020
- First submitted
- 25 Feb 2020
- Last updated
- 2 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26755405Langevin 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.
PubMed 25420010Boyles 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.
PubMed 22851876Kanlayanaphotporn 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.
PubMed 20205574Forbush 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.
PubMed 21891879
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Segmental Mobilization and Entire Segmental Spine Mobilization in Cervical Spondylosis
- ClinicalTrials.gov ID
- NCT04287634
- Acronym / sponsor ID
- Kiran REC-00296
- Conditions
- Cervical Spondylosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 14 Jul 2018 (actual)
- First posted
- 27 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Segmental Mobilization | Experimental | Other: Segmental MobilizationHot Fermentation Soft tissue mobilization + Targeted Segmental Mobilization Home plan exercise= cervical muscles stretching, postural care |
| Entire Spine Mobilization | Experimental | Other: Entire Spine MobilizationHot fermentation Soft tissue mobilization + Entire spine mobilization Home plan exercises=cervical muscles stretches, postural care |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Symptoms of Cervical Spondylosis more than month
- Limited Cervical ROM (at least any 2 ROM)
Key exclusion criteria (6 listed)
- Positive Vertebrobasilar Insufficiency \& Sharp Purser Test
- Spinal stenosis.
- Osteoporosis.
- Trauma.
- Spondylosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Segmental MobilizationHot fermentation =10 minutes Soft tissue mobilization =5 minutes Targeted segmental mobilization= 3 sets of 10 repetitions Home plan exercise= cervical muscles stretching, postural care. | Other | Segmental Mobilization |
| Entire Spine MobilizationHot fermentation=10 minutes Soft tissue mobilization=5 minutes Entire spine mobilization =3 sets of 10 repetitions Home plan exercises=cervical muscles stretches, postural care. | Other | Entire Spine Mobilization |
Primary outcome
Neck Disability Index
Time frame: 3 Week
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)
Time frame: 3 Week
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
Time frame: 3 Week
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2020.
- Background: PubMed 26755405Celenay 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.
- Background: PubMed 25420010Langevin 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.
- Background: PubMed 22851876Boyles 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.
- Background: PubMed 20205574Kanlayanaphotporn 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.
- Background: PubMed 21891879Forbush 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.
- Individual participant dataSharing planned: No
Related trials for Cervical Spondylosis
Enrolling by invitation
Assessing Microbiome in Primary Anterior Cervical Fusion Patients
Cervical Stenosis, Myelopathy
Not yet recruiting
Validating Blinding Maintenance of a Sham-Sensitization Control Design for Sensitization Acupuncture Trials
Knee Osteoarthritis; Insomnia; Cervical Spondylosis; Chronic Low Back Pain; Allergic Rhinitis
Recruiting
Hard Cervical Collar Use Following Posterior Cervical Fusion
Spinal Stenosis Cervical, Radiculopathy, Cervical Region
Recruiting
Effectiveness of Pressure Biofeedback-Assisted Deep Cervical Flexor Training With and Without Scapular Stabilization Exercises on Pain, Range of Motion and Neck Disability in Cervical Spondylosis
Cervical Spondylosis
RecruitingObservational study
Prospective Case Series Evaluating 6-Month and 12-Month Outcomes After Cryoneurolysis for Chronic Pain
Chronic Pain, PERIPHERAL NEUROPATHY
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdul Ghafoor Sajjad, Phd* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Segmental Mobilization and Entire Spine Mobilization in people with Cervical Spondylosis, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck Disability Index (time frame: 3 Week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04287634, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2020.