Back or Neck Pain of at Least 2 Weeks DurationNCT00565942
Exploring Integrative Medicine in Swedish Primary Care
A study testing Integrative care in people with Back or Neck Pain of at Least 2 Weeks Duration, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Research over the last years have reported an increased popularity of complementary therapies (CTs) and an integration of CTs into mainstream medical settings, health care organizations and insurance plans. These trends may present both new challenges and new opportunities for health care provision. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Back or Neck Pain of at Least 2 Weeks Duration
- What is being tested?
- Integrative care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2004to Nov 2007
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Back/neck pain with or without headache for at least two weeks and at least three times per week
- Resident of Stockholm County
- Literate in Swedish
- Willing and able to comply with study requirements
Who cannot join
- Specific pathology and severe causes of back/neck pain such as malignant disease, vertebral fractures and severe or progressive neurological symptoms.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Karolinska Institutet, Department of Neurobiology, Care Sciences and Society, Division of Nursing
Huddinge, 141 83
About this study
Official title: Exploring Integrative Medicine for Back and Neck Pain - A Pragmatic Randomized Clinical Pilot Trial
Research over the last years have reported an increased popularity of complementary therapies (CTs) and an integration of CTs into mainstream medical settings, health care organizations and insurance plans. These trends may present both new challenges and new opportunities for health care provision. In Sweden and elsewhere, major challenges include the great variety and quality of CT provision within health care and a lack of national and international recommendations of how integrations of CTs with conventional care should be modelled, i.e. lack of conceptual models for delivering integrative medicine (IM). This may partly be a result of a scarce evidence base in support of IM provision within public health care services, e.g. lack of IM compared to usual care in randomised clinical trials. It remains largely unknown whether comprehensive models of IM are clinically or cost effectively different from conventional care provision.
Back and neck pain are costly, conventionally managed in primary care and two of the most common conditions treated by CTs. We have developed a comprehensive collaborative consensus model for IM adapted to Swedish primary care. The aim of this pilot study was to explore the feasibility of a pragmatic randomised clinical trial to investigate the effectiveness of the IM model versus conventional primary care in the management of patients with non-specific back/neck pain.
Read the detailed description
Study objectives included the exploration of recruitment and retention rates, patient and care characteristics, clinical differences and effect sizes between groups, selected outcome measures and power calculations to inform the basis of a full-scale trial.
- Being tested
- Integrative care, Usual care
- Keywords
- Integrative medicine, Primary care, Swedish massage therapy, Manual therapy, Naprapathy, Shiatsu, Acupuncture, Qigong, Pragmatic ranomized controlled pilot trial, Health services research
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrative careProcedure or surgery
In short, integrative care was up to 10 complementary therapy treatments delivered to the patient in addition to the usual care over an intervention period of up to 12 weeks. The integrative care was provided by a multidisciplinary team coordinated by a gate keeping general practitioner with clinical knowledge and experience of CTs and senior licensed/certified CT providers representing Swedish massage therapy, manual therapy/naprapathy, shiatsu, acupuncture and qigong.
Usual careProcedure or surgery
The usual care treatment was coordinated by the patient's general practitioner and complied with the clinical practice routines at the participating primary care units. Conventional procedures included but were not exclusive to advice, prescription of drugs, sick leave and physiotherapy/physical therapy. There were no constraints to the provided usual care as the study aimed to pragmatically reflect the general practitioners' standard care and treatment as usual.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Active comparator | Treatment as usual coordinated by general practitioners in primary care. Receives: Procedure: Usual care |
| Integrative care | Active comparator | Selected complementary therapies (Swedish massage therapy, manual therapy/naprapathy, shiatsu, acupuncture and qigong) added to usual care. Receives: Procedure: Integrative care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days with pain
Number of days with pain over the last two weeks (0-14 days)
Measured: Change from baseline to follow-up after 16 weeks
Physical functioning
SF-36 domain 0-100 (higher score better)
Measured: Change from baseline to follow-up after 16 weeks
Role physical
SF-36 domain 0-100 (higher score better)
Measured: Change from baseline to follow-up after 16 weeks
Bodily pain
SF-36 domain 0-100 (higher score better)
Measured: Change from baseline to follow-up after 16 weeks
General health
SF-36 domain 0-100 (higher score better)
Measured: Change from baseline to follow-up after 16 weeks
Vitality
SF-36 domain 0-100 (higher score better)
Measured: Change from baseline to follow-up after 16 weeks
Social functioning
SF-36 domain 0-100 (higher score better)
Measured: Change from baseline to follow-up after 16 weeks
Role emotional
SF-36 domain 0-100 (higher score better)
Measured: Change from baseline to follow-up after 16 weeks
Mental health
SF-36 domain 0-100 (higher score better)
Measured: Change from baseline to follow-up after 16 weeks
Disability
Numerical rating scale 0-10 (higher score worse)
Measured: Change from baseline to follow-up after 16 weeks
Stress
Numerical rating scale 0-10 (higher score worse)
Measured: Change from baseline to follow-up after 16 weeks
Well-being
Numerical rating scale 0-10 (higher score better)
Measured: Change from baseline to follow-up after 16 weeks
Use of prescription analgesics
Use of prescription analgesics during the last two weeks (yes/no)
Measured: Change from baseline to follow-up after 16 weeks
Use of non-prescription analgesics
Use of non-prescription analgesics during the last two weeks (yes/no)
Measured: Change from baseline to follow-up after 16 weeks
Use of conventional care
Use of conventional care during the last two weeks (yes/no)
Measured: Change from baseline to follow-up after 16 weeks
Use of complementary care
Use of complementary care during the last two weeks (yes/no)
Measured: Change from baseline to follow-up after 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2007 (estimated)
- Study startSep 2004
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Back or Neck Pain of at Least 2 Weeks DurationStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Ekhagastiftelsen, Insamlingsstiftelsen för forskning om manuella terapier, Primary care units at Bagarmossen, Skarpnäck, Dalen and Björkhagen, Svensk förening för vetenskaplig homeopati, HRQL gruppen, Göteborgs universitet
- Responsible party
- Principal investigator, Torkel Falkenberg, Karolinska Institutet
- Investigators
- Torkel Falkenberg, PhD, Principal investigator, Karolinska Institutet, Department of Neurobiology, Care Sciences and Society, Division of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00565942
- Sponsor's protocol ID
- IM in Swedish primary care
- Status last verified
- Oct 2020
- First submitted
- 28 Nov 2007
- Last updated
- 29 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Sundberg T, Halpin J, Warenmark A, Falkenberg T. Towards a model for integrative medicine in Swedish primary care. BMC Health Serv Res. 2007 Jul 10;7:107. doi: 10.1186/1472-6963-7-107.
PubMed 17623105Sundberg T, Petzold M, Wandell P, Ryden A, Falkenberg T. Exploring integrative medicine for back and neck pain - a pragmatic randomised clinical pilot trial. BMC Complement Altern Med. 2009 Sep 7;9:33. doi: 10.1186/1472-6882-9-33.
PubMed 19735542
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Integrative Medicine for Back and Neck Pain - A Pragmatic Randomized Clinical Pilot Trial
- ClinicalTrials.gov ID
- NCT00565942
- Acronym / sponsor ID
- IM in Swedish primary care
- Keywords
- Integrative medicine, Primary care, Swedish massage therapy, Manual therapy, Naprapathy, Shiatsu, Acupuncture, Qigong
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Ekhagastiftelsen, Insamlingsstiftelsen för forskning om manuella terapier, Primary care units at Bagarmossen, Skarpnäck, Dalen and Björkhagen, Svensk förening för vetenskaplig homeopati, HRQL gruppen, Göteborgs universitet
- Study start
- Sep 2004
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 30 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Research over the last years have reported an increased popularity of complementary therapies (CTs) and an integration of CTs into mainstream medical settings, health care organizations and insurance plans. These trends may present both new challenges and new opportunities for health care provision. In Sweden and elsewhere, major challenges include the great variety and quality of CT provision within health care and a lack of national and international recommendations of how integrations of CTs with conventional care should be modelled, i.e. lack of conceptual models for delivering integrative medicine (IM). This may partly be a result of a scarce evidence base in support of IM provision within public health care services, e.g. lack of IM compared to usual care in randomised clinical trials. It remains largely unknown whether comprehensive models of IM are clinically or cost effectively different from conventional care provision.
Back and neck pain are costly, conventionally managed in primary care and two of the most common conditions treated by CTs. We have developed a comprehensive collaborative consensus model for IM adapted to Swedish primary care. The aim of this pilot study was to explore the feasibility of a pragmatic randomised clinical trial to investigate the effectiveness of the IM model versus conventional primary care in the management of patients with non-specific back/neck pain.
Detailed description
Study objectives included the exploration of recruitment and retention rates, patient and care characteristics, clinical differences and effect sizes between groups, selected outcome measures and power calculations to inform the basis of a full-scale trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | Active comparator | Procedure: Usual careTreatment as usual coordinated by general practitioners in primary care. |
| Integrative care | Active comparator | Procedure: Integrative careSelected complementary therapies (Swedish massage therapy, manual therapy/naprapathy, shiatsu, acupuncture and qigong) added to usual care. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Back/neck pain with or without headache for at least two weeks and at least three times per week
- Resident of Stockholm County
- Literate in Swedish
- Willing and able to comply with study requirements
Key exclusion criteria (1 listed)
- Specific pathology and severe causes of back/neck pain such as malignant disease, vertebral fractures and severe or progressive neurological symptoms.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrative careIn short, integrative care was up to 10 complementary therapy treatments delivered to the patient in addition to the usual care over an intervention period of up to 12 weeks. The integrative care was provided by a multidisciplinary team coordinated by a gate keeping general practitioner with clinical knowledge and experience of CTs and senior licensed/certified CT providers representing Swedish massage therapy, manual therapy/naprapathy, shiatsu, acupuncture and qigong. | Procedure or surgery | Integrative care |
| Usual careThe usual care treatment was coordinated by the patient's general practitioner and complied with the clinical practice routines at the participating primary care units. Conventional procedures included but were not exclusive to advice, prescription of drugs, sick leave and physiotherapy/physical therapy. There were no constraints to the provided usual care as the study aimed to pragmatically reflect the general practitioners' standard care and treatment as usual. | Procedure or surgery | Usual care |
Primary outcome
Days with pain
Time frame: Change from baseline to follow-up after 16 weeks
Number of days with pain over the last two weeks (0-14 days)
Physical functioning
Time frame: Change from baseline to follow-up after 16 weeks
SF-36 domain 0-100 (higher score better)
Role physical
Time frame: Change from baseline to follow-up after 16 weeks
SF-36 domain 0-100 (higher score better)
Bodily pain
Time frame: Change from baseline to follow-up after 16 weeks
SF-36 domain 0-100 (higher score better)
General health
Time frame: Change from baseline to follow-up after 16 weeks
SF-36 domain 0-100 (higher score better)
Vitality
Time frame: Change from baseline to follow-up after 16 weeks
SF-36 domain 0-100 (higher score better)
Social functioning
Time frame: Change from baseline to follow-up after 16 weeks
SF-36 domain 0-100 (higher score better)
Role emotional
Time frame: Change from baseline to follow-up after 16 weeks
SF-36 domain 0-100 (higher score better)
Mental health
Time frame: Change from baseline to follow-up after 16 weeks
SF-36 domain 0-100 (higher score better)
Disability
Time frame: Change from baseline to follow-up after 16 weeks
Numerical rating scale 0-10 (higher score worse)
Stress
Time frame: Change from baseline to follow-up after 16 weeks
Numerical rating scale 0-10 (higher score worse)
Well-being
Time frame: Change from baseline to follow-up after 16 weeks
Numerical rating scale 0-10 (higher score better)
Use of prescription analgesics
Time frame: Change from baseline to follow-up after 16 weeks
Use of prescription analgesics during the last two weeks (yes/no)
Use of non-prescription analgesics
Time frame: Change from baseline to follow-up after 16 weeks
Use of non-prescription analgesics during the last two weeks (yes/no)
Use of conventional care
Time frame: Change from baseline to follow-up after 16 weeks
Use of conventional care during the last two weeks (yes/no)
Use of complementary care
Time frame: Change from baseline to follow-up after 16 weeks
Use of complementary care during the last two weeks (yes/no)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2020.
- Background: PubMed 17623105Sundberg T, Halpin J, Warenmark A, Falkenberg T. Towards a model for integrative medicine in Swedish primary care. BMC Health Serv Res. 2007 Jul 10;7:107. doi: 10.1186/1472-6963-7-107.
- Results publication: PubMed 19735542Sundberg T, Petzold M, Wandell P, Ryden A, Falkenberg T. Exploring integrative medicine for back and neck pain - a pragmatic randomised clinical pilot trial. BMC Complement Altern Med. 2009 Sep 7;9:33. doi: 10.1186/1472-6882-9-33.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Torkel Falkenberg, PhD principal investigator
Karolinska Institutet, Department of Neurobiology, Care Sciences and Society, Division of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrative care in people with Back or Neck Pain of at Least 2 Weeks Duration, run by Karolinska Institutet at 1 site in Sweden.
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 4 inclusion and 1 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 29 Oct 2020. 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 Sweden. 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?
Days with pain (time frame: Change from baseline to follow-up after 16 weeks). The study lists 16 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 NCT00565942, which also lists 2 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 29 Oct 2020.