NCT06858124

Brief Summary

Non-specific neck pain (NSNP) is a prevalent musculoskeletal condition with multiple contributing factors. The aim of this clinical study is to investigate the short-term effects of Mulligan in comparison to Maitland mobilization techniques in conjunction with a home-based therapeutic exercise program. 43 adults with non-specific neck pain will be randomly divided into three groups of 14,14 and 15 participants each. In the participants of the first group, a therapeutic protocol of Mulligan mobilizations in the cervical region will be applied and a protocol of exercises will be performed. To the participants of the second group, a therapeutic protocol od Maitland mobilizations in the cervical region will be applied and the same exercise program with the first group will be performed. The third group participants will perform only the same exercise protocol as the other groups. The first two groups will receive four mobilization treatments over two weeks. All three groups will perform the home-based exercise protocol daily for two weeks. Pain in the last 24 hours with the Numeric Pain Rating Scale (NPRS), Pressure Pain Threshold (PPT) in the cervical region with an algometer, functional ability with the Neck Disability Index (NDI), Range of Motion (ROM) with a digital goniometer, pain catastrophizing with the Pain Catastrophizing Scale (PCS) and kinesiophobia with the Tampa Scale of Kinesiophobia (TSK) will be evaluated before and after the intervention. For the statistical analysis of the results, a two-way repeated measures analysis of variance (ANOVA) will be applied using SPSS program, while the statistical significance index will be set at p \< .05.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2025

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

First Submitted

Initial submission to the registry

February 27, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

February 27, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 5, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2025

Completed
Last Updated

April 16, 2025

Status Verified

April 1, 2025

Enrollment Period

1 month

First QC Date

February 27, 2025

Last Update Submit

April 11, 2025

Conditions

Keywords

Non-Specific Neck PainMulliganMaitland

Outcome Measures

Primary Outcomes (6)

  • Changes in neck pain intensity with Numeric Pain Rating Scale (NPRS)

    This tool is an 11-point scale from 0 ("no pain") to 10 ("worst imaginable pain"). Consequently, a higher value indicates more intense pain. The participant selects a number that best represents their pain intensity. The NPRS is a well-validated tool commonly used to measure pain intensity in clinical practice and research.

    pre-treatment, week: 2

  • Changes in Pressure Pain Threshold (PPT) with pressure algometry

    Pressure pain threshold (PPT) is defined as the minimal amount of pressure that produces pain. PPT will be assessed by a digital algometer and will be evaluated bilaterally in the upper trapezius muscle, between C7 and the acromion. The rubber tip of the algometer will be placed vertically on the site and the examiner will apply gradually increasing pressure in a rate of 1Kg/s.

    pre-treatment, week: 2

  • Changes in cervical range of motion with digital goniometry

    The cervical ROM of cervical flexion, extension, side bends and rotations will be assessed using a digital goniometer with the patient in the seated position. Each movement will be carried out once within the maximum pain-free range and will be documented by an independent physiotherapist

    pre-treatment, week: 2

  • Changes in functional ability with Neck Disability Index (NDI)

    The Neck Disability Index (NDI), validated for the Greek population, will be used to assess disability. It comprises 10 sections that evaluate pain intensity, functional restrictions, and daily activities, with a total score ranging from 0 (no disability) to 50 (severe disability).

    pre-treatment, week: 2]

  • Changes in pain catastrophizing with Pain Catastrophizing Scale (PCS

    The Pain Catastrophizing Scale (PCS) will be used to assess pain catastrophizing. It is a 13-item questionnaire designed to assess catastrophic thinking related to pain. Scores range from 0 to 52, with higher scores reflecting greater levels of catastrophizing across the subscales of rumination, magnification, and helplessness. The Greek version demonstrates high reliability (ICC = 0.85, Cronbach's α = 0.80).

    pre-treatment, week: 2]

  • Changes in kinesiophobia with Tampa Scale of Kinesiophobia (TSK)

    Kinesiophobia will be evaluated using the Tampa Scale of Kinesiophobia (TSK), a 17-item questionnaire that assesses fear of movement and anxiety related to injury. Scores range from 17 to 68, with ≤37 indicating low kinesiophobia and \>37 representing high kinesiophobia. The Greek version has demonstrated good reliability (Cronbach's α = 0.74, ICC = 0.78).

    pre-treatment, week: 2

Study Arms (3)

Mulligan+TE

EXPERIMENTAL

Participants allocated to this group will receive four sessions of Mulligan mobilizations and will perform a home-based therapeutic exercise program for two weeks.

Other: Mulligan+TE

Maitland +TE

EXPERIMENTAL

Participants allocated to this group will receive four sessions of Maitland mobilizations and will perform a home-based therapeutic exercise program for two weeks.

Other: Maitland+TE

Active Comparator: "TE group".

ACTIVE COMPARATOR

Participants in this group will only perform the same 4 home-based therapeutic exercises as the first group.

Interventions

Mulligan Mobilizations plus Home Therapeutic Exercise The protocol will last 25 minutes (Mulligan protocol: 5 minutes and Home Therapeutic Exercise protocol: 20 minutes) and will include the application of the following mulligan techniques and home exercises: * Mulligan sustained natural apophyseal glide SNAG mobilizations with overpressure with the patients in seated position. * 4 home-based therapeutic exercises: isometric exercises for cervical regions, head retractions, thoracic spine rotation mobility exercise and diagonal cervical mobility exercise pattern.

Mulligan+TE

The participants of this group will perform the same 4 home-based therapeutic exercises as the first group. In addition, they will receive a 5-minute maitland mobilization protocol. Maitland mobilizations will include posterioranterior glides with oscillations with the patients in prone position.

Maitland +TE
ControlOTHER

Participants in this group will only perform the same 4 home-based therapeutic exercises as the first group.

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Acute-subacute-chronic neck pain
  • Women - Men
  • Age range between 18 and 30 years
  • NPRS score \>2
  • Written consent to participate in the study

You may not qualify if:

  • Previous cervical/thoracic surgery
  • Recent whiplash (≤6 months)
  • Upper cervical pathology
  • Osteoporosis
  • Pregnancy
  • Cancer
  • Systemic diseases or spinal disorders
  • Neurological symptoms
  • Severe medical conditions, positive red flags (Spurling test, Hoffmann's sign, Babinski reflex, clonus)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Hellenic University

Thessaloniki, 57400, Greece

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
NA
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
A masked assessor will conduct the measurements
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 43 participants with non-specific neck pain pain will be randomly assigned to three groups of 14, 14 and 15 participants each. The allocation of the sample to the groups will be performed using the randomization app Randomiser (Rob Sammons, Apple Store) by an independent researcher. In the first group, a mulligan mobilization protocol will be applied and the practitioners will follow a daily therapeutic exercise program at home, in the second group, a maitland mobilization protocol will be applied and the practitioners will follow a daily therapeutic exercise program at home, while the third group will follow only a daily therapeutic exercise program at home. Participants of the two intervention groups will follow a total of four treatments over a period of two weeks. The therapeutic home-based exercise program will be performed daily over the same period of two weeks.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 27, 2025

First Posted

March 5, 2025

Study Start

February 27, 2025

Primary Completion

April 5, 2025

Study Completion

April 5, 2025

Last Updated

April 16, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations