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

Sponsor

Foundation University Islamabad (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05777408

Collaborator

(none)

Enrollment

Location

Arms

5.9

Anticipated Duration (Months)

3.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Neck Pain	Procedure: Conventional Physical Therapy Procedure: Natural Apophyseal glides Procedure: Cranial Base Release	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control Group 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.	Procedure: Conventional Physical Therapy 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 Procedure: Natural Apophyseal glides -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.
Experimental: Experimental Group 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	Procedure: Conventional Physical Therapy 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 Procedure: Natural Apophyseal glides -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. Procedure: Cranial Base Release 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

Arm

Intervention/Treatment

Active Comparator: Control Group

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.

Procedure: Conventional Physical Therapy

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

Procedure: Natural Apophyseal glides

-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.

Experimental: Experimental Group

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

Procedure: Conventional Physical Therapy

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

Procedure: Natural Apophyseal glides

Procedure: Cranial Base Release

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

Outcome Measures

Primary Outcome Measures

Change in Pain [2 weeks]
Pain will be measured on Numeric Pain Rating Scale.
Change in ROM [2 weeks]
Cervical rotation will be measured through CROM device
Change in Cervical Proprioception [2 weeks]
Will be measured from Laser Pointer Method

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Foundation University College of Physical Therapy	Rawalpindi	Punjab	Pakistan	46000

Sponsors and Collaborators

Foundation University Islamabad

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Foundation University Islamabad

ClinicalTrials.gov Identifier:

NCT05777408

Other Study ID Numbers:

FUI/CTR/2023/3

First Posted:

Mar 21, 2023

Last Update Posted:

Mar 21, 2023

Last Verified:

Mar 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Foundation University Islamabad

Range of Motion, Proprioception

Additional relevant MeSH terms:

Neck Pain

Study Results

No Results Posted as of Mar 21, 2023