Chronic Widespread PainNCT00521807
Hypnosis as a Treatment of Chronic Widespread Pain in General Practice. A Pilot Study.
A study testing Hypnosis in people with Chronic Widespread Pain, run by University of Oslo at 1 site in Norway.
Trial summary
Objective: The study was performed to evaluate the effect of a standardized hypnosis treatment used in general practice for patients with chronic widespread pain (CWP). Design: A randomized control group-controlled study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Widespread Pain
- What is being tested?
- Hypnosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2001to May 2005
- 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 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Chronic widespread pain for at least three months and at most five years.
Who cannot join
- Patients having primarily other organic diseases or serious psychiatric disorders were excluded.
Trial locations and contacts
1 site in 1 country.
Norway1 site
1) Institute of General Practice and Community Medicine, University of Oslo
Oslo, 0318
About this study
Objective: The study was performed to evaluate the effect of a standardized hypnosis treatment used in general practice for patients with chronic widespread pain (CWP).
Design: A randomized control group-controlled study. Setting and subjects: 16 patients were randomized into a treatment group or a control group, each constituting eight patients. Seven patients in the treatment group completed the schedule. After the control period, five of the patients in the control group also received treatment, making a total of 12 patients having completed the treatment sessions.
Read more
Intervention: The intervention group went through a standardized hypnosis treatment with ten consecutive therapeutic sessions once a week, each lasting for about 30 minutes, focusing on ego-strengthening, relaxation, releasing muscular tension and increasing self-efficacy.
Main outcome measures: A questionnaire was developed in order to calibrate the symptoms before and after the 10 weeks period, and the results were interpolated into a scale from 0 to 100, increasing numbers representing increasing suffering.
- Conditions
- Chronic Widespread Pain
- Being tested
- Hypnosis
- Keywords
- Hypnosis,, Chronic widespread pain,, CWP,, General Practice
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypnosisProcedure or surgery
a standardized hypnosis treatment with ten consecutive therapeutic sessions once a week,
| Study group | Role | What they receive |
|---|---|---|
| A 1 | No intervention | Not described |
| A 2 | Experimental | Treatment group Receives: Procedure: Hypnosis |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2007 (estimated)
- Study startMar 2001
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Widespread PainStudies of the same condition, open and under way.
- 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Investigators
- Jan R Grondahl, Dr, Principal investigator, The Institute of General Practice and Community Medicine, University of Oslo, Norway.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00521807
- Sponsor's protocol ID
- 26035831907
- Status last verified
- Aug 2007
- First submitted
- 27 Aug 2007
- Last updated
- 20 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Grondahl JR, Rosvold EO. Hypnosis as a treatment of chronic widespread pain in general practice: a randomized controlled pilot trial. BMC Musculoskelet Disord. 2008 Sep 18;9:124. doi: 10.1186/1471-2474-9-124.
PubMed 18801190
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypnosis as a Treatment of Chronic Widespread Pain in General Practice. A Pilot Study.
- ClinicalTrials.gov ID
- NCT00521807
- Acronym / sponsor ID
- 26035831907
- Conditions
- Chronic Widespread Pain
- Keywords
- Hypnosis,, Chronic widespread pain,, CWP,, General Practice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Study start
- Mar 2001
- Study completion
- May 2005 (actual)
- First posted
- 28 Aug 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.
Objective: The study was performed to evaluate the effect of a standardized hypnosis treatment used in general practice for patients with chronic widespread pain (CWP).
Design: A randomized control group-controlled study. Setting and subjects: 16 patients were randomized into a treatment group or a control group, each constituting eight patients. Seven patients in the treatment group completed the schedule. After the control period, five of the patients in the control group also received treatment, making a total of 12 patients having completed the treatment sessions.
Intervention: The intervention group went through a standardized hypnosis treatment with ten consecutive therapeutic sessions once a week, each lasting for about 30 minutes, focusing on ego-strengthening, relaxation, releasing muscular tension and increasing self-efficacy.
Main outcome measures: A questionnaire was developed in order to calibrate the symptoms before and after the 10 weeks period, and the results were interpolated into a scale from 0 to 100, increasing numbers representing increasing suffering.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A 1 | No intervention | – |
| A 2 | Experimental | Procedure: HypnosisTreatment group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Chronic widespread pain for at least three months and at most five years.
Key exclusion criteria (1 listed)
- Patients having primarily other organic diseases or serious psychiatric disorders were excluded.
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 |
|---|---|---|
| Hypnosisa standardized hypnosis treatment with ten consecutive therapeutic sessions once a week, | Procedure or surgery | A 2 |
Primary outcome
Not reported in the source record.
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 20 Oct 2008.
- Derived from this study: PubMed 18801190Grondahl JR, Rosvold EO. Hypnosis as a treatment of chronic widespread pain in general practice: a randomized controlled pilot trial. BMC Musculoskelet Disord. 2008 Sep 18;9:124. doi: 10.1186/1471-2474-9-124.
Related trials for Chronic Widespread Pain
Not yet recruiting
Effects of Adding Vagal Neuromodulation to Manual Therapy in Women With Fibromyalgia
Fibromyalgia (FM) OR Fibromyalgia Syndrome, Manuel Therapy
RecruitingObservational study
Overlapping Pain Trajectory Study
Migraine, Musculoskeletal Pain
Not yet recruiting
Hyperthermia in Patients With Chronic Primary Pain - Effects on Thermoregulation, Somatosensory System and Movement Evoked Pain
Hyperthermia, Chronic Primary Pain
Recruiting
Shiatsu for Chronic Non-Inflammatory Pain in Children and Adolescents
Chronic Pain, Chronic Pain Syndrome
RecruitingObservational study
Thoracolumbar Fascia Thickness in Women With Fibromyalgia
Fibromyalgia
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.
Jan R Grondahl, Dr principal investigator
The Institute of General Practice and Community Medicine, University of Oslo, Norway.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnosis in people with Chronic Widespread Pain, run by University of Oslo at 1 site in Norway.
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 1 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 20 Oct 2008. 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 Norway. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00521807, which also lists 1 linked publication.
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 20 Oct 2008.