NCT03089021

Brief Summary

This study investigate the short term effect of Maitland in comparison to Mulligan mobilization with sub-acute and chronic non specific neck pain to improve neck pain, pain pressure threshold, rang of motion, joint position sense, disability, and to evaluate the interaction with psychological factors. Study design: experimental study

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

Status
unknown

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

December 20, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 24, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2017

Completed
Last Updated

September 20, 2017

Status Verified

September 1, 2017

Enrollment Period

11 months

First QC Date

March 20, 2017

Last Update Submit

September 19, 2017

Conditions

Nonspecific Neck Pain

Keywords

neck pain,

Outcome Measures

Primary Outcomes (2)

  • pain pressure threshold

    It will be measured with an electronic algometer (Somedic AB, Farsta, Sweden) with a circular probe of 1 cm2. The PPT will be measured over the following site: (1) area of maximum tenderness over the cervical spine as identify by palpation, (2) tibialis anterior muscle (upper one-third of the muscle belly) bilateral. Tibialis anterior sites will be as remote lower limb sites to investigate any widespread changes in sensitivity. The pressure will be applied perpendicular over the identified sites at a rate of 40 KPa/s until the individual verbally states that the pressure is starting to change to a pain sensation. Then, the pressure will be stopped. The test will be repeated three times for each site within 30 second between measurements. An average of three measurements will be calculated

    3 weeks

  • pain intensity

    : numeric pain rating scale (NPRS) will be used to evaluate the intensity of pain perceived by patient. Pain is rated on 11 point scale from (0) no pain to (10) sever pain. The patients will be asked to point out the number that describes their pain level.

    3 weeks

Secondary Outcomes (3)

  • cervical range of motion

    3 weeks

  • joint position sense

    3 weeks

  • neck disability index

    3 weeks

Other Outcomes (4)

  • State trait anxiety inventory questionnaire (STAI-Y):

    3 weeks

  • Beck depression inventory questionnaire (BDI)

    3 weeks

  • Fear avoidance believe questionnaire (FABQ)

    3 weeks

  • +1 more other outcomes

Study Arms (2)

mulligan mobilization

EXPERIMENTAL

mobilization for spinous process or facet with neck movement 10 repetetions for 3 times.

Other: mulligan mobilization

maitland mobilization

EXPERIMENTAL

maitland mobilization for spinous process or facet joint for 2 min and repeated 3 times.

Other: maitland mobilization

Interventions

mulligan mobilizationOTHER

mobilization with movement for spinous process or facet joint.

mulligan mobilization
maitland mobilizationOTHER

posterioanterior of spinous process or facet joint.

maitland mobilization

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients aged between 20 to 50 years.
  • Neck pain more than one week without radicular symptoms.
  • Pain on posterior neck from superior nuchal line to first thoracic vertebra.

You may not qualify if:

  • Patient contraindicate to mobilization (pregnancy, whiplash injury, tumor, fracture, metabolic diseases, rheumatoid arthritis, osteoporosis and resting blood pressure higher than 140/90 mmHg).
  • Cervical radiculopathy.
  • Fibromyalgia pain syndrome.
  • Previous neck surgery.
  • Neck pain associate with vertigo caused by vertebrobasilar insufficiency or chronic headache.
  • Patient received physical therapy treatment in the previous three months.
  • Psychiatric disorders.
  • Vestibular system deficits.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Abdulaziz Hospital

Jeddah, Saudi Arabia

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • samar alansari, master

    Imam Abdulrahman Bin Faisal University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physical therapist

Study Record Dates

First Submitted

March 20, 2017

First Posted

March 24, 2017

Study Start

December 20, 2016

Primary Completion

November 1, 2017

Study Completion

December 28, 2017

Last Updated

September 20, 2017

Record last verified: 2017-09

Locations

SA(1)