NCT06460532

Brief Summary

Mechanical neck pain is defined as pain and discomfort localized between the superior nuchal line, cervical spine, and the spinous process of the first thoracic vertebra. Some of the most typical factors include continuous use of mobile phones and computers, working in sedentary jobs, etc. Study aimed to compare diaphragm manual therapy and Sustained Natural Apophyseal Glide on pain, range of motion and functional disability in patients with mechanical neck pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2024

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 14, 2024

Completed
16 days until next milestone

Study Start

First participant enrolled

June 30, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2024

Completed
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

3 months

First QC Date

June 11, 2024

Last Update Submit

October 10, 2024

Conditions

Keywords

disabilitymuscle strengthpainRange of Motion

Outcome Measures

Primary Outcomes (3)

  • Numeric Pain Rating Scale (NPRS)

    The primary outcome was pain assessment by the Numeric Pain Rating Scale (NPRS). This is a reliable self-reported 11-point numeric scale, where each number reflects the intensity of the pain referred by the patient: "0" stands for "no pain" and "10" for "the worst possible pain". Patients verbally selected 3 values that were most in line with the intensity of pain that they had experienced in the previous 24 h, corresponding to current pain and to his/her best and worst pain. The average of the 3 ratings was used to represent the patient's level of pain over the previous 24 h. NPRS was assessed before and after each treatment session. The reliability is (r = 0.96 and 0.95, respectively) and validity correlations range from 0.86 to 0.95

    upto 4 weeks

  • Neck disability Index (NDI)

    Disability was assessed using the Urdu version of the Neck Disability Index (NDI). This is a reliable scale and was self-assessed by the patients and filled in at the beginning and at the end of the whole treatment. The results of this questionnaire have been utilized to evaluate the disability. It consists of 10 items: 7 linked to activities of daily living, 2 to pain, and 1 to concentration. From 0 to 5, each item received a score. Higher scores corresponded to more disability, and the total score was reported as a percentage. The reliability is between 0.50 and 0.98.

    upto 4 weeks

  • Universal Goniometer

    An instrument called a goniometer was used to measure a joint's range of motion. Physical therapists typically use a goniometer to measure a range of motion. At the initial evaluation, the therapist can determine the possible range of motion using a goniometer. The reliability is (r = .58). Neck ROM will be measured in this study using a Universal Goniometer.

    upto 4 weeks

Study Arms (2)

Group A: Diaphragm Manual Therapy

EXPERIMENTAL

Group A were receiving diaphragm Manual therapy by Leon Chaitow. Subsequently, in order to indirectly stretch and mobilize the fibres of the diaphragm, diaphragmatic manual therapy was used, which should result in improved muscle contraction and reduced tension. The doming diaphragmatic technique and the manual diaphragmatic release technique, both as described by Leon Chaitow, will be among the experimental methods employed. For 10 min, both manoeuvres were performed in 2 sets of 10 repetitions each, separated by 1 min.

Other: Baseline treatment

Group B: Sustained Natural Apophyseal Glide (SNAGs)

ACTIVE COMPARATOR

Group B has received the Sustained natural apophyseal glide (SNAGS). Treatment procedure for SNAGs was sustained natural apophyseal glides whereby the patient attempts to actively move a painful or stiff joint through its ROM while the therapist overlays an accessory glide parallel with the treatment plane. SNAG mobilization was given to a patient (as defined by Mulligan) sitting on a chair. At the same time, the treating physiotherapist stood behind by placing the medial border of the distal phalanx of the thumb on the spine of one vertebra above the affected region. The glides were given with the tip of the thumb placed at an angle of 45° along the eyeball direction reinforced by another thumb. In the session, glides were repeated six times, and three sets were given at C3-C7 cervical levels.

Other: Baseline treatment

Interventions

Transcutaneous Electric Nerve Stimulation (TENS) of Care Vision company will be applied, with a pulse duration of 250 microseconds at a frequency of 80 Hz for 15 min in the suboccipital region and the trapezius bilaterally.

Group A: Diaphragm Manual TherapyGroup B: Sustained Natural Apophyseal Glide (SNAGs)

Eligibility Criteria

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

You may qualify if:

  • Age group between 18 and 40 years
  • Both gender male and female
  • Individuals having localized pain or stiffness in the cervical spine or both combined between C3 and C7 without upper-limb radiculopathy
  • Pain reported on NPRS score ˃3 to \<7/10 in neck region for more than 3 months.
  • Limited Neck ROM
  • Negative Spurling's test, traction test, upper limb tension test, and shoulder abduction test

You may not qualify if:

  • Patients were excluded if they were diagnosed with the following conditions for ˃6 months
  • Tuberculosis, carcinoma, heart disease, and osteoporosis
  • Neural disorders due to prolapsed intervertebral disc
  • Any trauma or localized infection in neck region
  • Upper motor neuron disease, cervical stenosis, and metabolic diseases in bone and joint
  • Hyper flexibility
  • Open sores
  • Ongoing radiotherapy, chemotherapy, steroid therapy, or anticoagulants
  • Psychiatric diseases such as phobia/obsession and depression
  • Allergy to hot pack
  • Patients with history of surgery in cervical spine region with in a year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sehat Medical Complex

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (7)

  • Saleem I, Zahoor IA, Rana AA, Sarfraz S, Ibrahim M, Ghaffar N. Comparison of Sustained Natural Apophyseal Glide and Natural Apophyseal Glide Effects on Pain, Range of Motion and Neck Disability in Patients with Chronic Neck Pain: Comparison of Sustained Natural Apophyseal Glide and Natural Apophyseal Glide Effects. Pakistan Journal of Health Sciences. 2022:154-8.

    BACKGROUND
  • Tatsios PI, Grammatopoulou E, Dimitriadis Z, Koumantakis GA. The Effectiveness of Manual Therapy in the Cervical Spine and Diaphragm, in Combination with Breathing Reeducation Exercises, in Patients with Non-Specific Chronic Neck Pain: Protocol for Development of Outcome Measures and a Randomized Controlled Trial. Diagnostics (Basel). 2022 Nov 4;12(11):2690. doi: 10.3390/diagnostics12112690.

    PMID: 36359533BACKGROUND
  • Pal A, Misra A. EFFECTIVENESS OF SNAG MOBILIZATION ON COMPUTER PROFES-SIONALS WITH MECHANICAL NECK PAIN AND MOBILITY DEFICIT. Int J Physiother Res. 2019;7(2):3022-27.

    BACKGROUND
  • Haghighat F, Moradi R, Rezaie M, Yarahmadi N, Ghaffarnejad F. Added Value of Diaphragm Myofascial Release on Forward Head Posture and Chest Expansion in Patients With Neck Pain: A Randomized Controlled Trial. 2020.

    BACKGROUND
  • Simoni G, Bozzolan M, Bonnini S, Grassi A, Zucchini A, Mazzanti C, Oliva D, Caterino F, Gallo A, Da Roit M. Effectiveness of standard cervical physiotherapy plus diaphragm manual therapy on pain in patients with chronic neck pain: A randomized controlled trial. J Bodyw Mov Ther. 2021 Apr;26:481-491. doi: 10.1016/j.jbmt.2020.12.032. Epub 2021 Feb 16.

    PMID: 33992285BACKGROUND
  • Jabbar KM, Gandomi F. The comparison of two corrective exercise approaches for hyperkyphosis and forward head posture: A quasi-experimental study. J Back Musculoskelet Rehabil. 2021;34(4):677-687. doi: 10.3233/BMR-200160.

    PMID: 33896809BACKGROUND
  • Bernal-Utrera C, Gonzalez-Gerez JJ, Anarte-Lazo E, Rodriguez-Blanco C. Manual therapy versus therapeutic exercise in non-specific chronic neck pain: a randomized controlled trial. Trials. 2020 Jul 28;21(1):682. doi: 10.1186/s13063-020-04610-w.

    PMID: 32723399BACKGROUND

MeSH Terms

Conditions

Neck PainPain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Anam Akram, MSPT*

    Riphah International University,Lahore

    PRINCIPAL INVESTIGATOR
  • samrood Akram

    Riphah International University

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

June 11, 2024

First Posted

June 14, 2024

Study Start

June 30, 2024

Primary Completion

September 30, 2024

Study Completion

October 10, 2024

Last Updated

October 15, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations