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

August 11, 2025 updated by: Foundation University Islamabad
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Rawalpindi, Punjab, Pakistan, 46000
        • Foundation University College of Physical Therapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Pain
Time Frame: 2 weeks
Pain will be measured on Numeric Pain Rating Scale.
2 weeks
Change in ROM
Time Frame: 2 weeks
Cervical rotation will be measured through CROM device
2 weeks
Change in Cervical Proprioception
Time Frame: 2 weeks
Will be measured from Laser Pointer Method
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Foundation University Islamabad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 9, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 21, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FUI/CTR/2023/3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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