Cervical RadiculopathyNCT04915222
Manual Cervical Traction and Natural Apophyseal Glides for Cervical Radiculopathy Patients
A study testing Natural apophyseal glides and Cervical manual traction in people with Cervical Radiculopathy, run by University of Lahore at 1 site in Pakistan.
Trial summary
Cervical Radiculopathy is a clinical disorder of nerve root, and often is due to compressive or inflammatory pathology. There are number of different procedures which have been suggested for decreasing pain and disability in patients but manual therapy has been validated the effective technique. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Cervical Radiculopathy
- What is being tested?
- Natural apophyseal glides and Cervical manual traction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Sep 2018to 15 Mar 2019
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects with clinically and radiologically diagnosed cervical radicular disease
- Subjects with difficulties in carrying out daily activities due to radicular pain
- Subject with bilateral/unilateral or both radicular pain
- Both male, female patients between 20 and 60 years with the radicular pain
Who cannot join
- Subjects having the mechanical cervical pain or the nonspecific pain of neck
- Subjects having cervical myelopathy
- Patients having any spine surgery or any malignancy
- Subjects having pain because of postural imbalances
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Physiotherapy Department of Mayo Hospital
Lahore, Punjab Province, 54000
About this study
Official title: Comparison Between the Effectiveness of Manual Cervical Traction and Natural Apophyseal Glides on Pain and Disability Among Patients With Cervical Radiculopathy
Cervical Radiculopathy is a clinical disorder of nerve root, and often is due to compressive or inflammatory pathology. There are number of different procedures which have been suggested for decreasing pain and disability in patients but manual therapy has been validated the effective technique. The objective of current research was to assess the comparative effectiveness of the Manual Cervical Traction and the Natural Apophyseal Glides on pain and disability among Cervical Radiculopathy patients.
A parallel design, randomized controlled trial was performed on 72 patients in physiotherapy department, Mayo Hospital Lahore. Participants were randomly allocated into two groups after baseline testing. Group A received natural apophyseal glides and baseline treatment and group B received manual cervical traction and baseline treatment. Treatment period was of 3 weeks with 3 weekly sessions on alternate basis. Assessment was done before treatment at baseline and then by second and third week using numeric pain rating scale and neck disability index. SPSS version 25 was used to analyzed the data.
Read the detailed description
72 patients who fulfill the inclusion criteria were enrolled in this study. Written informed consent was taken from every subject participating in this study. Allocation of subjects in two groups has been done by random number table as per CONSORT guidelines 2010. Group A was treated with Natural Apophyseal Glides and group B with Manual Cervical Traction. Both groups received the conventional therapy along with the manual techniques. The conventional therapy included hot pack, Neck range of motion exercises, neck strengthening and stabilization exercises. The hot pack is a form of thermo therapywas applied for 10 to 15 minutes and was applied at each visit during 3 sessions per week for total 3 weeks. The strengthening and stabilization exercises are form of therapeutics exercise are prescribed at 15 to 20 times per session for total 3 weeks. Intensity of exercise may rise gradually according to patient tolerance and muscular strength.The conventional or baseline therapy remained same throughout the study.
Group A received conventional therapy and NAGS with 2-3 hertz (less than 6 repetitions) in 3 sets for 3 weeks. Group B received MCT along with traditional therapy. Treatment frequency was 3 sessions per week for total three weeks duration. MCT applied was intermittent type traction.8 to 10 kg force was applied at an angle of 20 to 25 degree from horizontal. 5sets of cervical traction are performed. In every set traction is given for 1 minute with rest period of 20 seconds. The total time of session was 10 minute.Pain intensity was measured by Numeric Pain Rating Scale. Functional ability was appraised by Neck Disability Index. All the information was collected by using standardized questionnaire of NPRS and NDI. Confounding variables are controlled by randomization and restriction methods. All treatment was given by single handed to control the biasness.Proforma of the patients which dropout during study was filled through intention to treat analysis method which was set as 15%.
- Conditions
- Cervical Radiculopathy
- Being tested
- Natural apophyseal glides, Cervical manual traction
- Keywords
- Cervical radiculopathy, manual traction, neck pain
- Medical subject headings
- Radiculopathy, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Natural apophyseal glidesOther
Patients received conventional therapy and NAGS with 2-3 hertz (less than 6 repetitions) in 3 sets for 3 weeks. The conventional therapy included hot pack, Neck range of motion exercises, neck strengthening and stabilization exercises. The hot pack is a form of thermo therapywas applied for 10 to 15 minutes and was applied at each visit during 3 sessions per week for total 3 weeks. The strengthening and stabilization exercises are form of therapeutics exercise are prescribed at 15 to 20 times per session for total 3 weeks. Intensity of exercise may rise gradually according to patient tolerance and muscular strength.
Cervical manual tractionOther
Patients received cervical manual traction (CMT) along with traditional therapy. Treatment frequency was 3 sessions per week for total three weeks duration. CMT applied was intermittent type traction.8 to 10 kg force was applied at an angle of 20 to 25 degree from horizontal. 5sets of cervical traction are performed. In every set traction is given for 1 minute with rest period of 20 seconds. The total time of traction session was 10 minute. The conventional therapy included hot pack, Neck range of motion exercises, neck strengthening and stabilization exercises. The hot pack is a form of thermo therapywas applied for 10 to 15 minutes and was applied at each visit during 3 sessions per week for total 3 weeks. The strengthening and stabilization exercises are form of therapeutics exercise are prescribed at 15 to 20 times per session for total 3 weeks. Intensity of exercise may rise gradually according to patient tolerance and muscular strength.
| Study group | Role | What they receive |
|---|---|---|
| Natural apophyseal glides | Experimental | This group receives natural apophyseal glides along with conventional physical therapy and manual techniques as treatment for 3 sessions per week on alternate days for 3 weeks Receives: Other: Natural apophyseal glides |
| Cervical manual traction | Active comparator | This group receives cervical manual traction along with conventional physical therapy and manual techniques as treatment for 3 sessions per week on alternate days for 3 weeks Receives: Other: Cervical manual traction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Numeric Pain Rating Scale
Pain intensity was measured using numeric pain rating scale
Measured: Baseline and 3 weeks
Change from Baseline in Neck Disability Index
Functional ability was measured using neck disability index
Measured: Baseline and 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start10 Sep 2018
- Primary completion15 Mar 2019
- Study completion15 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical RadiculopathyStudies of the same condition, open and under way.
- More trials run by University of LahoreThe sponsor's other registered studies.
- 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
- Model description
- Single center, parallel group randomized controlled trial of 72 participants.
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Collaborators
- King Edward Medical University
- Responsible party
- Principal investigator, Mariam Ghazanfar, University of Lahore
- Investigators
- Mariam Ghazanfar, Principal investigator, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04915222
- Sponsor's protocol ID
- 129/RC/KEMU
- Status last verified
- May 2021
- First submitted
- 31 May 2021
- Last updated
- 7 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Effectiveness of Manual Cervical Traction and Natural Apophyseal Glides on Pain and Disability Among Patients With Cervical Radiculopathy
- ClinicalTrials.gov ID
- NCT04915222
- Acronym / sponsor ID
- 129/RC/KEMU
- Conditions
- Cervical Radiculopathy
- Keywords
- Cervical radiculopathy, manual traction, neck pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Collaborators
- King Edward Medical University
- Study start
- 10 Sep 2018 (actual)
- Primary completion
- 15 Mar 2019 (actual)
- Study completion
- 15 Mar 2019 (actual)
- First posted
- 7 Jun 2021 (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.
Cervical Radiculopathy is a clinical disorder of nerve root, and often is due to compressive or inflammatory pathology. There are number of different procedures which have been suggested for decreasing pain and disability in patients but manual therapy has been validated the effective technique. The objective of current research was to assess the comparative effectiveness of the Manual Cervical Traction and the Natural Apophyseal Glides on pain and disability among Cervical Radiculopathy patients.
A parallel design, randomized controlled trial was performed on 72 patients in physiotherapy department, Mayo Hospital Lahore. Participants were randomly allocated into two groups after baseline testing. Group A received natural apophyseal glides and baseline treatment and group B received manual cervical traction and baseline treatment. Treatment period was of 3 weeks with 3 weekly sessions on alternate basis. Assessment was done before treatment at baseline and then by second and third week using numeric pain rating scale and neck disability index. SPSS version 25 was used to analyzed the data.
Detailed description
72 patients who fulfill the inclusion criteria were enrolled in this study. Written informed consent was taken from every subject participating in this study. Allocation of subjects in two groups has been done by random number table as per CONSORT guidelines 2010. Group A was treated with Natural Apophyseal Glides and group B with Manual Cervical Traction. Both groups received the conventional therapy along with the manual techniques. The conventional therapy included hot pack, Neck range of motion exercises, neck strengthening and stabilization exercises. The hot pack is a form of thermo therapywas applied for 10 to 15 minutes and was applied at each visit during 3 sessions per week for total 3 weeks. The strengthening and stabilization exercises are form of therapeutics exercise are prescribed at 15 to 20 times per session for total 3 weeks. Intensity of exercise may rise gradually according to patient tolerance and muscular strength.The conventional or baseline therapy remained same throughout the study.
Group A received conventional therapy and NAGS with 2-3 hertz (less than 6 repetitions) in 3 sets for 3 weeks. Group B received MCT along with traditional therapy. Treatment frequency was 3 sessions per week for total three weeks duration. MCT applied was intermittent type traction.8 to 10 kg force was applied at an angle of 20 to 25 degree from horizontal. 5sets of cervical traction are performed. In every set traction is given for 1 minute with rest period of 20 seconds. The total time of session was 10 minute.Pain intensity was measured by Numeric Pain Rating Scale. Functional ability was appraised by Neck Disability Index. All the information was collected by using standardized questionnaire of NPRS and NDI. Confounding variables are controlled by randomization and restriction methods. All treatment was given by single handed to control the biasness.Proforma of the patients which dropout during study was filled through intention to treat analysis method which was set as 15%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single center, parallel group randomized controlled trial of 72 participants.
| Arm | Type | Receives |
|---|---|---|
| Natural apophyseal glides | Experimental | Other: Natural apophyseal glidesThis group receives natural apophyseal glides along with conventional physical therapy and manual techniques as treatment for 3 sessions per week on alternate days for 3 weeks |
| Cervical manual traction | Active comparator | Other: Cervical manual tractionThis group receives cervical manual traction along with conventional physical therapy and manual techniques as treatment for 3 sessions per week on alternate days for 3 weeks |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subjects with clinically and radiologically diagnosed cervical radicular disease
- Subjects with difficulties in carrying out daily activities due to radicular pain
- Subject with bilateral/unilateral or both radicular pain
- Both male, female patients between 20 and 60 years with the radicular pain
Key exclusion criteria (4 listed)
- Subjects having the mechanical cervical pain or the nonspecific pain of neck
- Subjects having cervical myelopathy
- Patients having any spine surgery or any malignancy
- Subjects having pain because of postural imbalances
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 |
|---|---|---|
| Natural apophyseal glidesPatients received conventional therapy and NAGS with 2-3 hertz (less than 6 repetitions) in 3 sets for 3 weeks. The conventional therapy included hot pack, Neck range of motion exercises, neck strengthening and stabilization exercises. The hot pack is a form of thermo therapywas applied for 10 to 15 minutes and was applied at each visit during 3 sessions per week for total 3 weeks. The strengthening and stabilization exercises are form of therapeutics exercise are prescribed at 15 to 20 times per session for total 3 weeks. Intensity of exercise may rise gradually according to patient tolerance and muscular strength. | Other | Natural apophyseal glides |
| Cervical manual tractionPatients received cervical manual traction (CMT) along with traditional therapy. Treatment frequency was 3 sessions per week for total three weeks duration. CMT applied was intermittent type traction.8 to 10 kg force was applied at an angle of 20 to 25 degree from horizontal. 5sets of cervical traction are performed. In every set traction is given for 1 minute with rest period of 20 seconds. The total time of traction session was 10 minute. The conventional therapy included hot pack, Neck range of motion exercises, neck strengthening and stabilization exercises. The hot pack is a form of thermo therapywas applied for 10 to 15 minutes and was applied at each visit during 3 sessions per week for total 3 weeks. The strengthening and stabilization exercises are form of therapeutics exercise are prescribed at 15 to 20 times per session for total 3 weeks. Intensity of exercise may rise gradually according to patient tolerance and muscular strength. | Other | Cervical manual traction |
Primary outcome
Change from Baseline in Numeric Pain Rating Scale
Time frame: Baseline and 3 weeks
Pain intensity was measured using numeric pain rating scale
Change from Baseline in Neck Disability Index
Time frame: Baseline and 3 weeks
Functional ability was measured using neck disability index
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 7 Jun 2021.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data
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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.
Mariam Ghazanfar principal investigator
University of Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Natural apophyseal glides and Cervical manual traction in people with Cervical Radiculopathy, run by University of Lahore 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 4 inclusion and 4 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 7 Jun 2021. 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?
Change from Baseline in Numeric Pain Rating Scale (time frame: Baseline and 3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jun 2021.