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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03089021
Other study ID # IRB -PGS-2016-03-143
Secondary ID
Status Enrolling by invitation
Phase N/A
First received March 20, 2017
Last updated September 19, 2017
Start date December 20, 2016
Est. completion date December 28, 2017

Study information

Verified date September 2017
Source Dammam University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Description:

44 patients with sub-acute or chronic neck pain will be randomized into Maitland group: 22 patients receive central postro anterior or unilateral postero anterior. Mulligan group: 22 patients receive sustain natural apophyseal glides. The treatment will be 2 times /week for three weeks. Measurement will be taken pre intervention and after three weeks for neck pain, pain pressure threshold, range of motion, joint position sense, and disability using a numeric pain rating scale, pain pressure threshold test, cervical range of motion device, and neck disability index, depression, anxiety, fear avoidance believe and pain catestrophizing respectively.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 22
Est. completion date December 28, 2017
Est. primary completion date November 1, 2017
Accepts healthy volunteers No
Gender All
Age group 20 Years to 50 Years
Eligibility Inclusion Criteria:

- • 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.

Exclusion Criteria:

- • 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
mulligan mobilization
mobilization with movement for spinous process or facet joint.
maitland mobilization
posterioanterior of spinous process or facet joint.

Locations

Country Name City State
Saudi Arabia King Abdulaziz Hospital Jeddah

Sponsors (1)

Lead Sponsor Collaborator
Dammam University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type Measure Description Time frame Safety issue
Other State trait anxiety inventory questionnaire (STAI-Y): It has 20 items for assessing trait anxiety and 20 for state anxiety 3 weeks
Other Beck depression inventory questionnaire (BDI) it contains 21 items; each item has four self evaluation statements in a time frame of two weeks, and scores from 0 to 3. The total score for 21 items range from 0 to 63 3 weeks
Other Fear avoidance believe questionnaire (FABQ) this questionnaire can assess the fear avoidance believe about the pain. It consists of 16 items. First five questions are related to fear avoidance of physical activities (FABQ- PA). Then the eleven questions are related to avoidance of work (FABQ-W). The score for each question is ranged from 0 (strong disagreement) to 6 (strong agreement). The total score is ranged from 0 to 66. Higher score is represented high level of fear avoidance believe 3 weeks
Other pain catestrophizing scale 3 weeks
Primary 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
Primary 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 cervical range of motion it will be measured by cervical range of motion (CROM) device. It consists of three gravitational inclinometers system for flexion, extension and lateral flexion, and magnetic inclinometer for rotation. 3 weeks
Secondary joint position sense it will be measured by using the (CROM) device 3 weeks
Secondary neck disability index This questioner is used to report disability results from neck pain and it is a self-report based outcome. In addition, it contains ten sections with total score of 50 points 3 weeks
See also
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