NCT05777408

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

January 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 21, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

August 14, 2025

Status Verified

March 1, 2023

Enrollment Period

5 months

First QC Date

March 9, 2023

Last Update Submit

August 11, 2025

Conditions

Keywords

Range of Motion, Proprioception

Outcome Measures

Primary Outcomes (3)

  • Change in Pain

    Pain will be measured on Numeric Pain Rating Scale.

    2 weeks

  • Change in ROM

    Cervical rotation will be measured through CROM device

    2 weeks

  • Change in Cervical Proprioception

    Will be measured from Laser Pointer Method

    2 weeks

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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 TherapyProcedure: Natural Apophyseal glides

Experimental Group

EXPERIMENTAL

* 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 TherapyProcedure: Natural Apophyseal glidesProcedure: Cranial Base Release

Interventions

* 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

Control GroupExperimental Group

-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.

Control GroupExperimental Group

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

Experimental Group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University College of Physical Therapy

Rawalpindi, Punjab Province, 46000, Pakistan

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2023

First Posted

March 21, 2023

Study Start

January 1, 2023

Primary Completion

June 1, 2023

Study Completion

July 1, 2023

Last Updated

August 14, 2025

Record last verified: 2023-03

Locations