Manual Cervical Traction and Natural Apophyseal Glides for Cervical Radiculopathy Patients

NCT ID: NCT04915222

Last Updated: 2021-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-10
• Study Completion Date: 2019-03-15

Brief 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. 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%.

Conditions

Cervical Radiculopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Natural apophyseal glides

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

Group Type: EXPERIMENTAL

Natural apophyseal glides

Intervention Type: OTHER

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 traction

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

Group Type: ACTIVE_COMPARATOR

Cervical manual traction

Intervention Type: OTHER

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.

Interventions

Natural apophyseal glides

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.

Intervention Type: OTHER

Cervical manual traction

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King Edward Medical University

OTHER

Sponsor Role: collaborator

University of Lahore

OTHER

Sponsor Role: lead

Responsible Party

Mariam Ghazanfar

Senior Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mariam Ghazanfar

Role: PRINCIPAL_INVESTIGATOR

University of Lahore

Locations

Physiotherapy Department of Mayo Hospital

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

129/RC/KEMU

Identifier Type: -

Identifier Source: org_study_id