NCT05061121

Brief Summary

The aim of investigator's study is to combine and compare the two scientifically approved therapies for the CNSNP to investigate the short term and mid-term changes of the combination of these two manual techniques concerning pain, function, range of motion ROM and postural stability.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2021

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

August 31, 2021

Completed
29 days until next milestone

First Posted

Study publicly available on registry

September 29, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

September 7, 2022

Status Verified

September 1, 2022

Enrollment Period

3 months

First QC Date

August 31, 2021

Last Update Submit

September 2, 2022

Conditions

Keywords

CNSNPSNAGsMFR

Outcome Measures

Primary Outcomes (5)

  • pain intensity VAS

    visual analogue scale ,The pain VAS is a continuous scale formed of a horizontal (HVAS) or vertical (VVAS) line, 100 mm in length, ended with 2 verbal pain descriptor on either end one for each symptom extreme; "no pain" at the most left side of the line (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 /100-mm scale) on the rightest end

    15 mins

  • Pressure pain threshold PPT

    pressure algometer ,The PPT represents a hybrid test, falling somewhere between self-reported paper-and-pencil type tools and objective diagnostic techniques

    30 mins

  • function

    Neck Disability Index (NDI) This index consists of ten sections, including seven sections related to activities of daily living, two sections related to pain, and one section related to concentration. The score for each section is from 0 to 5, with 0 representing the highest level of function and 5 representing the lowest level of function. Total NDI-TH scores are shown as a percentage. A high score corresponds to a higher degree of disability. The internal consistency of the NDI-TH is high.

    15 mins

  • Range of motion

    Cervical range of motion device (CROM) The CROM device is a reliable outcome tool for measuring upper cervical rotation. The clinical implications of these findings suggest that therapists can utilize the CROM device to more completely examine all planes of upper and full cervical mobility. It may also assist in identifying upper cervical ROM limitations associated with underlying cervical pathology or motion dysfunction

    30 mins

  • postural stability

    Biodex Balance System (BBS) The Biodex balance system (BBS) uses a circular platform that is free to move in the anterior-posterior and medial-lateral axes simultaneously, which permits three measures to be obtained: an overall stability index (OSI), an anterior-posterior stability index (APSI), and a medial-lateral stability index (MLSI) will measure OSI ,APSI ,and MLSI

    30 mins

Study Arms (3)

sustained natural apophyseal glides

EXPERIMENTAL

Investigate the short- and mid-term effects of Mulligan's SNAGs on pain intensity, pain pressure sensitivity, cervical function, range of motion (ROM) and postural stability in CNSNP patients

Other: combined effect

Myofascial release

EXPERIMENTAL

Investigate the short- and mid-term effects of Myofascial release on pain intensity, pain pressure sensitivity, cervical function, range of motion (ROM) and postural stability in CNSNP patients

Other: combined effect

sustained natural apophyseal glides in addition to myofascial release

EXPERIMENTAL

Investigate the short- and mid-term effects of Mulligan's SNAGs combined with Myofascial release on pain intensity, pain pressure sensitivity, cervical function, range of motion (ROM) and postural stability in CNSNP patients

Other: combined effect

Interventions

Compare the short- and mid-term effects of Mulligan's SNAGs, Myofascial release, and their combination on pain intensity, pain pressure sensitivity, cervical function, range of motion (ROM) and postural stability in CNSNP patients

Myofascial releasesustained natural apophyseal glidessustained natural apophyseal glides in addition to myofascial release

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age ranged from 20-45 years
  • Current neck pain
  • Neck pain continued for at least the last 12 week
  • Pain with no obvious organic or pathologic cause.
  • The patients diagnosed as chronic non-specific neck pain through an orthopedic specialist, diagnostic investigations including X rays and MRI failed to show obvious pathological findings

You may not qualify if:

  • Irradiated neck pain
  • Neck pain associated with vertigo
  • Osteoporosis
  • Diagnosed psychological disorders
  • Vertebral fractures
  • Tumors
  • Diagnosed metabolic diseases
  • Previous neck surgery
  • Red flags (night pain, severe muscle spasm, loss of
  • involuntary weight, symptom mismatch)
  • Physiotherapeutic treatment continued in the last 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Misr University For Science and Technology

El-Sheikh Zayed City, Giza Governorate, 3236101, Egypt

Location

Related Publications (4)

  • 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
  • Binder A. The diagnosis and treatment of nonspecific neck pain and whiplash. Eura Medicophys. 2007 Mar;43(1):79-89.

    PMID: 17369782BACKGROUND
  • Hidalgo B, Hall T, Bossert J, Dugeny A, Cagnie B, Pitance L. The efficacy of manual therapy and exercise for treating non-specific neck pain: A systematic review. J Back Musculoskelet Rehabil. 2017 Nov 6;30(6):1149-1169. doi: 10.3233/BMR-169615.

    PMID: 28826164BACKGROUND
  • Gonzalez Rueda V, Lopez de Celis C, Barra Lopez ME, Carrasco Uribarren A, Castillo Tomas S, Hidalgo Garcia C. Effectiveness of a specific manual approach to the suboccipital region in patients with chronic mechanical neck pain and rotation deficit in the upper cervical spine: study protocol for a randomized controlled trial. BMC Musculoskelet Disord. 2017 Sep 5;18(1):384. doi: 10.1186/s12891-017-1744-5.

    PMID: 28870191BACKGROUND

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
SINGLE
Who Masked
PARTICIPANT
Masking Details
assigned randomly into Three equal groups the by using permuted block method
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Design of the study: Single-blinded randomized controlled trial design. Patients will be randomly assigned into 3 equal groups using the statistical package for social science (SPSS 20). Group A (Mulligan's SNAGs) Group B (Myofascial release) Group C (Mulligan's SNAGs + Myofascial release)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 31, 2021

First Posted

September 29, 2021

Study Start

December 1, 2021

Primary Completion

March 1, 2022

Study Completion

April 1, 2022

Last Updated

September 7, 2022

Record last verified: 2022-09

Locations