ClinicalTrials.gg
CompletedNCT04420403Updated Jan 4, 2022

Investigation of the Effectiveness of Manual Therapy Plus Cervical Stabilization Exercise in Chronic Neck Pain

An interventional study of Manual Therapy and Cervical Stabilazation Exercise (CSE) in Neck Pain, sponsored by Ataturk Training and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2022-01-04.

Sponsored by Ataturk Training and Research Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 296 studies in Neck Pain with a site in Turkey — 70 open to participants now, 78 under way, none of them phase 3. Neck Pain · Turkey.

Enrollment
210th of 216
20 · median 45
Started
2020
with 10 others
No phase
215 of 296
47 open now
Registered
27th of 296
by date

Among the 296 studies in Neck Pain with a site in Turkey, this one is the 210th largest by enrollment of the 216 interventional ones that give a count, is one of 11 that started in 2020, is one of 215 with no phase, and was the 27th registered.

Neck Pain

1,360 studies on the registry are indexed under Neck Pain; 299 are open to participants now.

Browse Neck Pain studies →

Open to participants now

70 of the 296 studies in Neck Pain with a site in Turkey are open now. Recruiting first, the newest first:

65 more — sign in →

All 70 open studies →

A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →

Who these studies take

Of the 155 Neck Pain studies recruiting now, 25 (16%) set no upper age limit and 117 (75%) stop at 75 or younger; 8 take children under 18; 26 take healthy volunteers.

This study: 18 Years to 55 Years · all sexes · no healthy volunteers.

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02

Study summary

This study aims to investigate the effectiveness of manual therapy plus cervical stabilization exercise compared to manual therapy alone on balance, proprioception, and neck muscle morphology in chronic neck pain.

Read the detailed description

Neck pain is defined as pain and/or stiffness localized to the dorsal area of the area between the condyle of the occiput and the third thoracic vertebra. Chronic neck pain (CNP), defined as persistent pain lasting three or more mounts, causes disability and a reduction in life quality. Balance disorders or postural instability, a deficit in proprioception, changes in muscle recruitment, a decrease in dimension of deep cervical muscle, and an increase in stiffness of superficial neck muscle may lead to pain in patients with CNP. Both manual therapy and exercise have favorable effects on management with CNP. According to our knowledge, no study has investigated the effects of manual therapy plus cervical stabilization exercise on balance, proprioception, and neck muscle morphology in CNP, yet.

03

Conditions studied

  • Neck Pain

Keywords

  • neck pain
  • manual therapy
  • exercise
  • postural control
04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 20 to 55 years of age,
  • Having generalized neck pain for more than 3 months,
  • Being volunteer

Exclusion criteria

Exclusion Criteria:

  • Being pregnant,
  • ,
  • Having cervical stenosis,
  • Severe cervical spondylosis,
  • Cervical fractures and tumor,
  • Osteoporosis,
  • Positive vertebrobasilar test
  • Positive Babinski reflex
  • Neurologic deficit related to compression of the spinal root or cord,
  • Having neurologic, dermatologic, infectious, inflammatory rheumatologic and endocrine diseases,
  • Being an inability to fulfill the questionnaires,
  • Any problems that will hinder exercise (advanced cardiopulmonary or orthopedic problems), having intervention including exercise program or physiotherapy in the three months
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Manual therapy plus cervical stabilization exercise group

    The patients diagnosed with chronic neck pain (CNP) with 18-55 years of age followed by routine controls and who were volunteered will be included in the study.

    Other: Manual Therapy · Other: Cervical Stabilazation Exercise (CSE)

  • Active comparator
    Only manual therapy group

    The patients diagnosed with CNP with 18-55 years of age followed by routine controls and who were volunteered will be included in the study.

    Other: Manual Therapy

Interventions

  • OtherManual Therapy

    Cyriax's mobilization techniques will be applied as manual therapy. Before the mobilization, soft tissue mobilization techniques will be applied to relieve muscular spasm and preventing the patient' s anxiety. Bringing, manual traction, manual traction with rotation, manual traction with anterior-posterior gliding and lateral gliding mobilization techniques will be applied. Appropriate mobility techniques will be selected according to the complaints and symptoms of the patients. Cervical mobilization applications will take an average of 15-20 minutes.

  • OtherCervical Stabilazation Exercise (CSE)

    The CSE program aims to maintain a neutral spine position and activate deep cervical muscles during exercises. It is performed in stages with gradual progression according to the stages of motor learning and sensory-motor integration, namely, static, dynamic, and functional. The program will start with postural training and then the cervical bracing technique with the activation of deep neck flexors for CSE was performed. The patients will be asked to maintain a neutral spine during the exercises and throughout the day as much as possible. The difficulty and variety of exercises will be increased weekly. It will be carried out 2 days a week for 6 weeks (12 sessions) by the supervisor physiotherapist.

06

What researchers measure

Primary outcomes

  1. Balance

    The balance will be evaluated with Biodex BioSwayTM Balance Evaluation System. It reliably measures the patient's ability to balance on soft and/or hard ground.

    Time frame: change from baseline at 6 weeks

Secondary outcomes

  1. Proprioception

    Proprioception will be assessed with dual digital inclinometer. The feet of the inclinometers will be placed as simultaneously as possible over the head of the patients and the cervical seventh vertebra. Firstly, patients will be asked to move their heads forward as possible as from the neutral position and then they will try to find neutral position from reached position. The angle on digital display of inclinometer will be recorded as degree. Each test will be repeated 3 times and the average deviation error score will be recorded.

    Time frame: change from baseline at 6 weeks

  2. Muscle morphology

    The thickness and stiffness of the neck muscles will be evaluated by a specialist radiologist with real-time ultrasonography. It is a reliable, valid and, non-invasive method that provides an assessment of muscle morphology. Measurements will be made by using the Logiq S7 / Expert ultrasound device. The cross-sectional area of deep neck muscle with sonography, the stiffness of the superficial muscles with elastography were assessed.

    Time frame: change from baseline at 6 weeks

  3. Pain intensity

    The pain intensity will be assessed with the Visual Analog Scale, which consists of a horizontal line of 10 cm in length. For pain level assessment, "0" defines "no pain" and "10" defines "unbearable pain''. The participants will be asked to mark the intensity of their pain level.

    Time frame: change from baseline at 6 weeks

  4. Disability level

    The disability level will be measured with the Turkish version of Neck Disability Index (NDI). It consists of 10 sections which include the severity of pain, personal care, lifting, reading, headache, concentration, work-life, driving, sleeping and leisure activities. There are 6 responses for each section, scored 0 (no pain and no functional limitation) and 5 (worst pain and maximum limitation). The total score ranges from 0 to 50. Patients will be asked to select the most appropriate option for each section.

    Time frame: change from baseline at 6 weeks

07

Study locations

1 site
  • Ankara Yildirim Beyazit University
    Ankara, 06760, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2020 to primary completion in Jun 2021, 12 months.

Of 763 non-industry interventional studies with no phase under Neck Pain, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 15. This study's 12 months is above that.

Counting every sponsor, half of 772 studies reached it within 7 months; a quarter within 3 and three quarters within 15.

How these figures are worked out, and which studies are left out of them.

Registered
May 29, 2020
First posted
Jun 9, 2020
StartActual
May 20, 2020
Primary completionActual
Jun 1, 2021
CompletionActual
Jun 24, 2021
Last update
Jan 4, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 4, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04420403
Lead sponsor
Ataturk Training and Research Hospital
Responsible party
Seyda TOPRAK CELENAY (associate professor, Ataturk Training and Research Hospital) — Principal investigator
First posted
Jun 9, 2020
Start date
May 20, 2020
Primary completion
Jun 1, 2021
Completion
Jun 24, 2021
Last update
Jan 4, 2022

Study contacts

seyda toprak celenay, PhD, PT
principal investigator · Ankara Yildirim Beyazıt University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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