NCT05234268

Brief Summary

To determine the effectiveness of Manual Cervical Traction, Passive Accessory Intervertebral Movements (PAIVMs) and Active strength training in the management of cervical radiculopathy. To compare the effectiveness of Manual Cervical Traction, Passive Accessory Intervertebral Movements (PAIVMs) and Active strength training in the management of cervical radiculopathy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 30, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 10, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2022

Completed
Last Updated

September 16, 2022

Status Verified

September 1, 2022

Enrollment Period

1.1 years

First QC Date

February 1, 2022

Last Update Submit

September 14, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • Pain Relief by Visual Analogue Scale (VAS)

    A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. The simplest VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom, pain, health) orientated from the left (worst) to the right (best).

    4 weeks

  • Activities of daily living by Neck Disability Index (NDI)

    This questionnaire has been designed to give us information as to how your neck pain has affected your ability to manage in everyday life. Patient-completed, condition- specific, functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. Each section is scored on a 0 to 5 rating scale, in which zero means "no pain" and 5 means "Worst imaginable pain".

    4 Weeks

  • Cervical Compression Test by Spurling's Test

    The Spurling's test (also known as Maximal Cervical Compression Test and Foraminal Compression Test) is used during a musculoskeletal assessment of the cervical spine when looking for cervical nerve root compression causing Cervical Radiculopathy. There are different ways described in the literature to perform the Spurling's test. The version that provoked upper limb symptoms the best was with the neck in extension, lateral flexion and axial compression.

    4 Weeks

Secondary Outcomes (2)

  • Cervical Range of motion by Goniometer

    4 Weeks

  • Endurance of the deep flexors of the cervical spine by Cranio-cervical Flexion Test

    4 week

Study Arms (3)

Manual Cervical Traction

EXPERIMENTAL

The patient is in supine lying. The head and neck of patient are held in the hands of the practitioner, and then a gentle traction of a pulling force is applied. Intermittent periods of traction can be applied, holding each position for about 10 seconds. Traction is usually applied at about 20-30 degrees of neck flexion.

Other: Manual Cervical Traction

Passive Accessory Intervertebral Movements

EXPERIMENTAL

Patient lying in prone. Therapist stands to side of patient placing their pisiform/ulnar surface of hand over the selected spinous process (SP) with their wrist in full extension. Other hand placed on top of hand to reinforce. Therapist's shoulders should be directly above the SP with elbows slightly bent. Therapist uses their body weight to apply a PA force to the selected SP by leaning their body over their arms and performing rocking movements to provide oscillatory movements of the vertebra.

Other: Passive Accessory Intervertebral Movements

Active Strength Training

EXPERIMENTAL

The progression of exercises will be done using different colours of Thera-band indicating varied resistance

Other: Active Strength Training

Interventions

Time: 20 minutes Duration: thrice a week for 4 weeks. Position: The patient is in supine lying. The head and neck of patient are held in the hands of the practitioner, and then a gentle traction of a pulling force is applied. Intermittent periods of traction can be applied, holding each position for about 10 seconds. Traction is usually applied at about 20-30 degrees of neck flexion.

Manual Cervical Traction

Time: 20 minutes Duration: thrice a week for 4 weeks Position: Patient lying in prone. Therapist stands to side of patient placing their pisiform/ulnar surface of hand over the selected spinous process (SP) with their wrist in full extension. Other hand placed on top of hand to reinforce. Therapist's shoulders should be directly above the SP with elbows slightly bent. Therapist uses their body weight to apply a PA force to the selected SP by leaning their body over their arms and performing rocking movements to provide oscillatory movements of the vertebra.

Passive Accessory Intervertebral Movements

Time: 20 minutes Duration: thrice a week for 4 weeks. The progression of exercises will be done using different colors of Thera-band indicating varied resistance. (A) Resistive lateral flexion of uninvolved side. Position: The patient is in sitting position. By the help of thera-band patient will actively flex the neck against resistance on the uninvolved side.

Active Strength Training

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosed with cervical radiculopathy due to muscle tightness or spasm (Diagnosed by Spurling's Test)
  • Having complaint more than 2 months

You may not qualify if:

  • Past history of cervical surgery
  • Past history of cervical trauma
  • Any inflammatory disease
  • Tumor or Carcinoma
  • Disco genic/ disc herniation or stenosis cause of radiculopathy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Quaid-e-Azam International Hospital

Rawalpindi, Punjab Province, 45200., Pakistan

Location

Pakistan Railway General Hospital

Rawalpindi, Punjab Province, 46000, Pakistan

Location

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Maria Khalid, MSPT-OMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2022

First Posted

February 10, 2022

Study Start

June 30, 2021

Primary Completion

August 1, 2022

Study Completion

August 5, 2022

Last Updated

September 16, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations