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Additional Effect of Cranial Base Release on Cervical Range and Proprioception in Patients With Mechanical Neck Pain

Primary Purpose

Neck Pain

Status
Active
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Conventional Physical Therapy
Natural Apophyseal glides
Cranial Base Release
Sponsored by
Foundation University Islamabad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring Range of Motion, Proprioception

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients diagnosed with mechanical neck pain having reproducible non-specific neck pain with a primary location between the supranuchal line and the first thoracic spinous process Male and Female Age 18-40 years Pain severity on NPRS >3 Neck Disability score of 20% or above Problem not older than 2 months Exclusion Criteria: Patients with history of Recent significant trauma (including whiplash) Radiculopathy Cervical fracture Neck surgery Dizziness, vertigo Myelopathy, Malignancy Metabolic disease Diagnosed Osteoporosis, Rheumatoid arthritis Long-term corticosteroid and/or painkiller drug use

Sites / Locations

  • Foundation University College of Physical Therapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group

Experimental Group

Arm Description

Participants of this group will receive the conventional physical therapy protocol mentioned above. In addition to this, they will receive Natural apophyseal glides 3 sets of 10 repetitions. Frequency: 3 times a week for 2 weeks. 6 sessions in total. Mobilizations will be performed in Grade 1 initially and then progressed to Grade 2 and 3 depending on the patients pain status and compliance.

Participants of this Group will receive the conventional physical therapy protocol mentioned above. In addition to this, they will receive Natural apophyseal glides and cranial base release. Frequency: 3 times a week for 2 weeks. 6 sessions in total. Cranial base release would be given for around 1-4minutes until the tissues relax and would be given once daily

Outcomes

Primary Outcome Measures

Change in Pain
Pain will be measured on Numeric Pain Rating Scale.
Change in ROM
Cervical rotation will be measured through CROM device
Change in Cervical Proprioception
Will be measured from Laser Pointer Method

Secondary Outcome Measures

Full Information

First Posted
March 9, 2023
Last Updated
March 20, 2023
Sponsor
Foundation University Islamabad
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1. Study Identification

Unique Protocol Identification Number
NCT05777408
Brief Title
Additional Effect of Cranial Base Release on Cervical Range and Proprioception in Patients With Mechanical Neck Pain
Official Title
Additional Effect of Cranial Base Release on Cervical Range and Proprioception in Patients With Mechanical Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Foundation University Islamabad

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Mechanical Neck pain is the second most commonly occurring musculoskeletal disorder worldwide, ranking 4th in overall disability. It is referred to as Nonspecific generalized neck pain with mechanical characteristics with a primary location between the supranuchal line and the first thoracic spinous process, includingpatients suffering from mechanical neck pain are reported to have several impairments, including pain, reduced cervical ROM, neck disability, and proprioceptive dysfunction. The treatment indicated involves the use of electrotherapy and thermal modalities. In addition, the use of different manual therapy techniques is advocated; however, the most effective management is still debatable. Evidence suggests that Natural Apophyseal glides have a significant positive effect on mechanical neck pain patients. So the study will identify the additional effect of cranial base release with natural apophyseal glides in alleviating pain and its effects on proprioception.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
Range of Motion, Proprioception

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a randomized controlled trial having two groups. One group will receive conventional physical therapy along with Natural apophyseal glides and the second will receive Natural Apophyseal Glides in addition to cranial base release with conventional physical therapy. Both groups will be recruited concurrently.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Participants of this group will receive the conventional physical therapy protocol mentioned above. In addition to this, they will receive Natural apophyseal glides 3 sets of 10 repetitions. Frequency: 3 times a week for 2 weeks. 6 sessions in total. Mobilizations will be performed in Grade 1 initially and then progressed to Grade 2 and 3 depending on the patients pain status and compliance.
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
Participants of this Group will receive the conventional physical therapy protocol mentioned above. In addition to this, they will receive Natural apophyseal glides and cranial base release. Frequency: 3 times a week for 2 weeks. 6 sessions in total. Cranial base release would be given for around 1-4minutes until the tissues relax and would be given once daily
Intervention Type
Procedure
Intervention Name(s)
Conventional Physical Therapy
Intervention Description
15 mins of TENS (frequency 100 Hz, phase duration 50 μs) with moist heat over the area of pain Isomeric Stretching of neck muscles followed by neck isometrics
Intervention Type
Procedure
Intervention Name(s)
Natural Apophyseal glides
Intervention Description
-Will be applied in sitting position Therapist right hand would cradle the head such that the little finger would rest on the spinous process of the vertebra that is to be mobilized. The other hands thumb would be used to apply over pressure. Direction of force will be parallel to highly irritable-grossly restricted cervical facet joints. Intervention would involve 3 sets of 20 repetitions in 15minutes, 3 days a week for 2 weeks comprising of total 6 session.
Intervention Type
Procedure
Intervention Name(s)
Cranial Base Release
Intervention Description
Will be performed in lying position. therapist fingers will contact the sub occipital muscles and upward pressure would be given until the tissues and muscles relax. it will be given once daily for 3 days a week and will continue for 2 weeks
Primary Outcome Measure Information:
Title
Change in Pain
Description
Pain will be measured on Numeric Pain Rating Scale.
Time Frame
2 weeks
Title
Change in ROM
Description
Cervical rotation will be measured through CROM device
Time Frame
2 weeks
Title
Change in Cervical Proprioception
Description
Will be measured from Laser Pointer Method
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients diagnosed with mechanical neck pain having reproducible non-specific neck pain with a primary location between the supranuchal line and the first thoracic spinous process Male and Female Age 18-40 years Pain severity on NPRS >3 Neck Disability score of 20% or above Problem not older than 2 months Exclusion Criteria: Patients with history of Recent significant trauma (including whiplash) Radiculopathy Cervical fracture Neck surgery Dizziness, vertigo Myelopathy, Malignancy Metabolic disease Diagnosed Osteoporosis, Rheumatoid arthritis Long-term corticosteroid and/or painkiller drug use
Facility Information:
Facility Name
Foundation University College of Physical Therapy
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
46000
Country
Pakistan

12. IPD Sharing Statement

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Additional Effect of Cranial Base Release on Cervical Range and Proprioception in Patients With Mechanical Neck Pain

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