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Neck PainNCT04605510

Acute Effect of Passive Joint Mobilization in Non-Specific Neck Pain

A study testing Passive Cervical Joint Mobilization in people with Neck Pain, run by Mücahit ÖZTOP at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Aim of present study is investigating the acute effects of passive joint mobilization on pain perception and range of motion. Study protocol includes passive joint mobilization application to study group with neck pain and blood sample collection of study and healthy control group. Read more about this study

Who is it for?
Ages 24 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Neck Pain
What is being tested?
Passive Cervical Joint Mobilization
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jan 2021to 23 May 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 24 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • For Intervention Group;
  • Having neck pain lasting more than 30 days and being diagnosed with non-specific neck pain
  • Having obtained 14/50 points and above in Neck Disability Index
  • Expressing neck pain at least 34/100 points and above on a Visual Analog Scale
  • Being 20-45 years old and female
  • For Healthy Control Group;
  • Healthy volunteers without a chronic illness and musculoskeletal pain

Who cannot join

  • Congenital anomalies
  • Previously diagnosed orthopedic diseases related to the spine
  • Pregnancy and having just given birth
  • Within the last 3 months; use of corticosteroids, cytotoxic drugs, or immunosuppressants
  • Liver or kidney failure
  • Acute or chronic infections (including HIV)
Show all 10Show fewer
  • Serious pathologies (such as cancer, spondylolisthesis, rheumatoid arthritis or ankylosing spondylitis)
  • Symptoms of cervical spinal stenosis (such as incoordination of hands, arms and legs, bowel and bladder incontinence)
  • Radix compression (such as sensory changes, muscle weakness or decreased reflexes)
  • Whiplash or a history of cervical surgery

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Pamukkale University School of Physical Therapy and Rehabilitation

    Denizli, 20000

Other trials in Turkey (Türkiye)

About this study

Official title: Acute Effect of Passive Joint Mobilization on Joint Motion And Pain Perception in Non-Specific Neck Pain

Aim of present study is investigating the acute effects of passive joint mobilization on pain perception and range of motion. Study protocol includes passive joint mobilization application to study group with neck pain and blood sample collection of study and healthy control group.

Read the detailed description

Our purpose of planning this study is to examine the acute effect of passive joint mobilization application on pain perception and range of motion in women with non-specific neck pain.

The hypotheses we will test for this purpose;

H1- Passive joint mobilization application increases the range of motion of the cervical joint in women with non-specific neck pain.

H2- Passive joint mobilization application increases the pressure pain threshold in women with non-specific neck pain.

H3- Passive joint mobilization increases serum Orexin A and Neurotensin levels in women with non-specific neck pain.

Conditions
Neck Pain
Being tested
Passive Cervical Joint Mobilization
Keywords
non-specific neck pain, passive joint mobilization, blood markers, neck range of motion
Medical subject headings
Neck Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Passive Cervical Joint MobilizationOther

    Also called Maitland Mobilization

    It will be applied to the cervical spine, whose dysfunction is detected as a result of the evaluation. The participant will be in the prone position and Grade 3 Central Posterior-Anterior (CPA) passive joint mobilization with Maitland method will be applied for 3 sets, 30 seconds, to the segment to be treated.

Study groups in NCT04605510
Study groupRoleWhat they receive
Intervention GroupExperimental24 female participants with non-specific neck pain included in the mobilization group will undergo detailed manual cervical examination. In the evaluation, the most painful segment with dysfunction will be selected and mobilization application and algometric measurements will be performed on this segment. Grade 3 Central Posterior-Anterior (CPA) passive joint mobilization with Maitland method will be applied in 3 sets, 30 seconds, to the segment with the detected dysfunction.
Receives: Other: Passive Cervical Joint Mobilization
Healthy Control GroupNo interventionHealthy volunteer participants included in the control group will only be applied an evaluation protocol and blood samples will be taken without any application.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cervical Range of Motion

    Cervical Range of Motion will be assessed by Baselşne Bubble Inclinometer as degree of flexion-extension, rotation and lateral flexion and will be recorded.

    Measured: Cervical Range of Motion assessment will take maximum of 5 minutes.

  2. Pain Pressure Threshold

    Pressure Pain Threshold will be measured with the JTech Commander Algometer at the level of the right and left zygapophyseal joint of the dysfunctional cervical segment detected during physical examination. During the evaluation, the participants will be asked to lie in a prone position. By placing the probe of the algometer vertically on the skin, the pressure applied will be gradually increased and the participant will be asked to report at the first moment of pain. The measurement will be made once and the result will be recorded in kilograms.

    Measured: Pain Pressure Threshold assessment will take maximum of 5 minutes.

  3. Neuropeptide Measurement

    Neuropeptide Measurement will be performed as a result of evaluating the blood samples taken from the participants with the appropriate ELISA kits. Orexin A and Neurotensin levels are planned to be evaluated with Human Orexin A (Competitive EIA) ELISA Kit and Human NTS / NT / Neurotensin (Competitive EIA) ELISA Kit which are specific for these neuropeptides.

    Measured: Blood Sample Collection for Neuropeptide Measurement will take maximum of 5 minutes.

Secondary outcomes (2)

  1. Pain Intensity Measurement

    Pain intensity will be evaluated with the Visual Analogue Scale. The Visual Analogue Scale is a horizontal scale in the range of 0-100 mm, where 0 is the lowest pain and 100 the highest pain. The patient will be asked to mark the pain felt in the neck area on this line and the point marked will be measured with a ruler and recorded in mm.

    Measured: Pain Intensity Measurement will take maximum of 1 minute.

  2. Neck Disability

    Neck Disability will be measured by Neck Disability Index. The Neck Disability Index is a frequently used scale to evaluate the level of disability due to neck pain. It consists of 10 items and 6 options under each item. Options are scored between 0-5 points. An increasing score indicates a higher level of disability. The minimum score that can be obtained from the scale is 0, and the highest score is 50. 14 points are used as cut-off points for the minimal level of disability.

    Measured: Neck Disability measurement will take maximum of 1 minute.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2020
  2. Study start1 Jan 2021
  3. Primary completion20 Jul 2021
  4. Study completion23 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
This study includes two groups. Intervention group including women with non-specific neck pain will applied cervical passive joint mobilization and assessment protocol. Control group including healthy women without pain will applied only assessment protocol.
Masking
None (open label)
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04605510
Sponsor's protocol ID
60116787-020/46072
Status last verified
May 2022
First submitted
22 Oct 2020
Last updated
25 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Plaza-Manzano G, Molina-Ortega F, Lomas-Vega R, Martinez-Amat A, Achalandabaso A, Hita-Contreras F. Changes in biochemical markers of pain perception and stress response after spinal manipulation. J Orthop Sports Phys Ther. 2014 Apr;44(4):231-9. doi: 10.2519/jospt.2014.4996. Epub 2014 Jan 22.

    PubMed 24450367

  • Molina-Ortega F, Lomas-Vega R, Hita-Contreras F, Plaza Manzano G, Achalandabaso A, Ramos-Morcillo AJ, Martinez-Amat A. Immediate effects of spinal manipulation on nitric oxide, substance P and pain perception. Man Ther. 2014 Oct;19(5):411-7. doi: 10.1016/j.math.2014.02.007. Epub 2014 Mar 5.

    PubMed 24674816

  • Lohman EB, Pacheco GR, Gharibvand L, Daher N, Devore K, Bains G, AlAmeri M, Berk LS. The immediate effects of cervical spine manipulation on pain and biochemical markers in females with acute non-specific mechanical neck pain: a randomized clinical trial. J Man Manip Ther. 2019 Sep;27(4):186-196. doi: 10.1080/10669817.2018.1553696. Epub 2018 Dec 11.

    PubMed 30935335

  • Maitland GD. Maitland's Vertebral Manipulation. Seventh Ed. (Hengeveld E, Banks K, eds.). Edinburgh; New York: Churchill Livingstone; 2013. https://www.elsevier.com/books/maitlands-vertebral-manipulation/hengeveld/978-0-7020-4066-5.

Questions about this trial

What is this clinical trial studying?

A study testing Passive Cervical Joint Mobilization in people with Neck Pain, run by Mücahit ÖZTOP at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cervical Range of Motion (time frame: Cervical Range of Motion assessment will take maximum of 5 minutes.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04605510, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2022; AzTrials last refreshed its copy on 6 Nov 2026.

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