Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000495325
Ethics application status
Approved
Date submitted
28/02/2017
Date registered
5/04/2017
Date last updated
10/10/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Manual therapy and stretching for neck pain
Scientific title
Manual therapy vs stretching exercises in treatment of chronic neck pain: a randomised controlled trial
Secondary ID [1] 291311 0
Nil known
Universal Trial Number (UTN)
U1111-1193-6022
Trial acronym
MT Neck Pain Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neck pain 302285 0
Condition category
Condition code
Musculoskeletal 301873 301873 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 301874 301874 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Manual therapy group. Patients will receive 2 treatments weekly for 5 weeks. Treatment will consist of 2 components: 1. Local cryotherapy during each session will be performed just before manual therapy. 2. Low-velocity osteopathic type mobilisation of cervical joint. No manipulations, i.e. high-velocity thrusts with low-amplitude, will be applied.
1. Local cryotherapy will be performed using KRIOPOL R 30 (Kriomedpol, Poland). A stream of cold nitrogen vapor at temperature -130 degrees Celsius will be applied during 3 minutes to the muscles on both sides of the cervical spine and to the muscles on both sides of the shoulder girdle. The distance among the apparatus nozzle and patients body surface will be 10 centimeters.
2. Manual therapy will be based on 6 osteopathic-type mobilisation techniques, which will be performed while the patient is placed supine.
A. Translation upwards: the head and upper cervical spine is lifted up by pushing the spinous processes with both hands to apply force to the movement segment lying between the lifted vertebra and the one immediately below it.
B. Translation sideways: the cervical vertebra is pushed alternately towards the right and the left side by force applied to each facet joint. Hands tightly support each side of the head and upper cervical column, which are moved directly sideways at each level being treated.
C. Side bending: the cervical spine is bent alternately to each side. Hands support along each side of the head and cervical column with the pads of the finger tips over the mobilised facet joint. The head and cervical column are bent to each side and finger tips are then moved upwards over the next facet joint.
D. Rotation and side bending in the same direction: the head is supported by the therapist's lower mid-abdomen and hands support the head and upper cervical spine. Hands overlie each other forming a bridge so that the heads of the metacarpal bones are over the facet joints. Prior to mobilisation the cervical column is moped sideways and rotated in the same direction to about half of total range of movement (ROM). The movement is then continued so that connective tissues become stretched without causing pain. The head and neck are returned after each movement to its starting position. The head is rotated to the other side for the same treatment.
E. Rotation with small ROM: the pads of the tips of the middle and the ring fingers are placed over the spinous processes and the fingers then are straightened so that the middle phalanx of the fingers is over the facet joint. The head is supported with the hand on the opposite side allowing the movement to happen and the head returns to the middle position. The other side is treated by moving to the opposite side of the treatment table.
F. Mobilization of upper cervical joints: both hands support the occiput with the tips of the middle and the ring fingers over the arch of the atlas on each side. The head is bent sideways slightly and turned in the opposite direction, causing the atlas to move against the finger tips. The mobilization will be performer 3 times in each direction. Each manual therapy session will not exceed 20 minutes.
The treating practitioner will be physiotherapists with post-graduate qualification in manual therapy, recognized as titled musculoskeletal physiotherapists or specialist musculoskeletal physiotherapists by Polish Physiotherapy Association and have at least 10 years experience. The treating practitioners will receive specific training in implementation of the trial protocol, work-health and safety induction and training in emergency procedures. The treatment will take place in the Physiotherapy Laboratory of the Regional Hospital.
Intervention code [1] 297339 0
Treatment: Other
Intervention code [2] 297340 0
Rehabilitation
Comparator / control treatment
Stretching group. Patients will receive cryotherapy and manual therapy, as the manual therapy group . Moreover, home exercises will be added. Patients will be also instructed to
keep an exercise diary to monitor their exercise frequency. Each exercise will be repeated 3 times, each movement will be holding for 30 seconds.
The patients will be advised to perform the stretching program 5 times a week, single session for 5 weeks will not exceed 20 minutes to perform.
The exercises will be performed in the following order; stretching towards lateral flexion for the upper part of the trapezius, ipsilateral flexion and rotation for the scalene and flexion for the extensor muscles. All of the exercises will be performed in a sitting position.
A. Stretching towards lateral flexion for the upper part of the trapezius: put your chest up and hold onto the chair with one hand. Turn your head toward the hand that is holding onto the chair. Use your free hand to pull your head straight toward the opposite side. To feel more stretch, lean your body slightly away from the hand that is holding onto the chair to depress your shoulder further.
B. Ipsilateral flexion and rotation for the scalene: put your chest up forward on the edge of a chair. Hold the leg or seat of the chair tightly with one hand to keep the ribs down. Sideflex your head to the opposite side without flexing your head forward. You may find you get more of a stretch if you rotate your head slightly toward the hand that is holding onto the chair and slightly extend your neck as you sideflex.
C. Flexion for the extensor muscles: put your chest up and look straight ahead. Gently push your chin back while looking straight ahead (so that you have a double chin). Keep your head upright, don't look up or down. Keep eyes facing forward. While holding your chin back with one hand, use your other hand to reach over the top of your head. Stabilize your chin back as you gently pull the top of your head forward.
D. Levator Scapula Stretch: put your hand up over your shoulder and bring your elbow back, pointing your elbow up to the ceiling. Use your left hand to pull your head forward and to the left.
E. Neck straightening exercise: first retract your head by tucking in your chin. While keeping your chin tucked in tilt your head back. You may want to assist this with your hands for comfort.
The same treating practitioners will be physiotherapists with post-graduate qualification in manual therapy, recognized as titled musculoskeletal physiotherapists or specialists of musculoskeletal physiotherapists by Polish Physiotherapy Association and have at least 10 years experience. The treating practitioners will receive specific training in implementation of the trial protocol, work-health and safety induction and training in emergency procedures. The treatment will take place in the Physiotherapy Outpatient Department of the Regional Hospital. Moreover, the treating practitioner will be supervising patients’ exercises at home, once per week for 5 weeks.
Control group
Active

Outcomes
Primary outcome [1] 301299 0
Numeric Pain Rating Scale
Timepoint [1] 301299 0
Baseline, immediate post-intervention (5 weeks)
Secondary outcome [1] 332263 0
Neck Disability Index
Timepoint [1] 332263 0
Baseline, immediate post-intervention (5 weeks)
Secondary outcome [2] 332264 0
Patient-Specific Functional Scale
Timepoint [2] 332264 0
Baseline, immediate post-intervention (5 weeks)

Eligibility
Key inclusion criteria
Adults of both sex aged 25-60 years, permanently employed, motivated to continue working, motivated for exercising and treatment, and constant or frequently occurring neck pain of more than 6 months’ duration.
Minimum age
25 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Specific disorders of the cervical spine, such as disc prolapse, spinal stenosis, postoperative conditions in the neck and shoulder areas, history of severe trauma, instability, spasmodic torticollis, migraine (frequency more often than twice per month), peripheral nerve entrapment, fibromyalgia, hypermobility syndrome, shoulder diseases (tendonitis, bursitis, capsulitis), inflammatory rheumatic diseases, severe psychiatric illness and other diseases that prevent physical loading, pregnancy and other on-going therapies.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sequentially numbered, sealed, opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by web-based computer program.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2017
Actual
8/06/2017
Date of last participant enrolment
Anticipated
29/07/2017
Actual
1/08/2017
Date of last data collection
Anticipated
Actual
7/08/2017
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 8701 0
Poland
State/province [1] 8701 0
Silesia

Funding & Sponsors
Funding source category [1] 295779 0
Other
Name [1] 295779 0
Holycross College
Country [1] 295779 0
Poland
Primary sponsor type
Individual
Name
Pawel Lizis
Address
Holycross College,
Pawel Lizis, PhD,
51, Mielczarskiego Str
25-709 Kielce
Country
Poland
Secondary sponsor category [1] 294628 0
None
Name [1] 294628 0
Address [1] 294628 0
Country [1] 294628 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297077 0
The Holycross College Ethics Committee
Ethics committee address [1] 297077 0
Ethics committee country [1] 297077 0
Poland
Date submitted for ethics approval [1] 297077 0
26/01/2017
Approval date [1] 297077 0
23/02/2017
Ethics approval number [1] 297077 0
KB12302/2017

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1542 1542 0 0
/AnzctrAttachments/372459-Ethics Committee.doc (Ethics approval)

Contacts
Principal investigator
Name 72894 0
Dr Wojciech Kobza
Address 72894 0
Physiotherapy Laboratory
al. Legionów 21A
34-300 Zywiec
Country 72894 0
Poland
Phone 72894 0
+48 695 951456
Fax 72894 0
Email 72894 0
[email protected]
Contact person for public queries
Name 72895 0
Pawel Lizis
Address 72895 0
Holycross College
51, Mielczarskiego Str.
25-709 Kielce
Country 72895 0
Poland
Phone 72895 0
+48 663 793 834
Fax 72895 0
Email 72895 0
[email protected]
Contact person for scientific queries
Name 72896 0
Pawel Lizis
Address 72896 0
Holycross College
51, Mielczarskiego Str.
25-709 Kielce
Country 72896 0
Poland
Phone 72896 0
+48 663 793 834
Fax 72896 0
Email 72896 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.