Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12611000107921
Ethics application status
Approved
Date submitted
28/01/2011
Date registered
1/02/2011
Date last updated
1/02/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Patient-Oriented versus Prescription-Oriented rehabilitation in the management of chronic mechanical neck pain: a randomized controlled trial.
Scientific title
In patients with chronic mechanical neck pain is a patient-oriented rehabilitation program more effective or as effective as a prescription-oriented one for pain and pain-related disability relief?
Secondary ID [1] 253501 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic mechanical neck pain 261048 0
Condition category
Condition code
Musculoskeletal 259190 259190 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 259191 259191 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patient-oriented rehabilitation: therapeutic exercises and/or physical modalities are prescribed according to patient clinical status before each therapeutic session starts.
All patients will be treated in a one-on-one modality by an experienced physiotherapist, that will not change during the whole treatment period, three times a week for a total of a 10 treatment sessions over a period of 4 weeks. The duration of each single therapy session may vary according to prescription from a minimum of 30 minutes to a maximum of 50 minutes.
Intervention code [1] 257934 0
Rehabilitation
Comparator / control treatment
Prescription-oriented rehabilitation: therapeutic exercises and/or physical modalities are prescribed at first medical referral on the basis of actual physical status, and never changed and/or adjusted during the whole treatment period.
All patients will be treated in a one-on-one modality by an experienced physiotherapist, that will not change during the whole treatment period, three times a week for a total of a 10 treatment sessions over a period of 4 weeks. The duration of each single therapy session may vary according to prescription from a minimum of 30 minutes to a maximum of 50 minutes.
Control group
Active

Outcomes
Primary outcome [1] 262040 0
Changes in pain level in both groups at the end of treatment, as measured by visual analog scale (VAS) score
Timepoint [1] 262040 0
Baseline
4 weeks after therapy ends
Primary outcome [2] 262041 0
Changes in disability level in both groups at the end of treatment, as measured by Neck Pain and Disability Score
Timepoint [2] 262041 0
Baseline
4 weeks after therapy ends
Secondary outcome [1] 273019 0
Treatment failure, which was defined by the number of patients who interrupted the treatment they had been assigned because of no benefit (no reduction in pain)
Timepoint [1] 273019 0
Treatment period

Eligibility
Key inclusion criteria
Neck pain predominantly located in the somatic referral zones of the cervical spine, with or without shoulder, arm or face irradiation and of at least moderate intensity (4 cm or more on a 10-cm visual analog scale labeled 0=no pain and 10= the worst pain possible).
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
clinical signs of radiculopathy (i.e., tendon reflex loss, myotomal weakness, sensory abnormalities); disc herniation as documented by MRI; cervical stenosis; history of neck trauma or previous spinal surgery; diabetic neuropathy; history of rheumatic, central and peripheral nervous system diseases; anxiety-depression syndromes; tumors; pregnancy; inability to read or comprehend the questionnaires

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 3162 0
Italy
State/province [1] 3162 0

Funding & Sponsors
Funding source category [1] 258402 0
Self funded/Unfunded
Name [1] 258402 0
Country [1] 258402 0
Italy
Primary sponsor type
University
Name
Sapienza University
Address
piazzale Aldo Moro, 5
00185 Rome
Country
Italy
Secondary sponsor category [1] 257550 0
None
Name [1] 257550 0
Address [1] 257550 0
Country [1] 257550 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Optimal management of chronic mechanical neck pain (CMNP) still represents a challenge for both clinician and researchers. Based on the current literature, it could be argued that optimal intervention may not exists because of the lack of accepted causative mechanisms of CMNP. Rehabilitative management of CMNP patients is usually performed in an outpatient facility, and is often based on a prescription-oriented (Pr-O) therapy. With this term, we intend the use of different therapeutic modalities (e.g. exercise, manipulation, physical therapies) usually prescribed at first medical referral on the basis of actual physical status, and never changed and/or adjusted during the whole treatment period. As a possible counter-party, a patient-oriented (Pa-O) therapy would ideally be scheduled for each patient at the beginning of each therapeutic session and based on his current physical status, thereby being similar to that prospected for severe disabilities, such as post-stroke hemiplegia. We hypothsize that a Pa-O approach may be more effective, in terms of pain management, than a Pr-O one in CMNP suffers.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32145 0
Address 32145 0
Country 32145 0
Phone 32145 0
Fax 32145 0
Email 32145 0
Contact person for public queries
Name 15392 0
Marco Paoloni
Address 15392 0
UOC Medicina Fisica e Riabilitativa
Dipartimento Scienze Apparato Locomotore
Azienda Policlinico Umberto I
piazzale Aldo Moro, 5
00185 Roma
Country 15392 0
Italy
Phone 15392 0
+39-6-491672
Fax 15392 0
Email 15392 0
[email protected]
Contact person for scientific queries
Name 6320 0
Marco Paoloni
Address 6320 0
UOC Medicina Fisica e Riabilitativa
Dipartimento Scienze Apparato Locomotore
Azienda Policlinico Umberto I
piazzale Aldo Moro, 5
00185 Roma
Country 6320 0
Italy
Phone 6320 0
+39-6-491672
Fax 6320 0
Email 6320 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.