Chronic PainPhase 2/3NCT01651338
Quality of Life and Acupuncture on Chronic Pain: A Randomized Study Before and After Performing
A Phase 2/3 study testing acupuncture in people with Chronic Pain, run by Islamic Azad University, Sanandaj at 1 site in Iran.
Trial summary
Chronic pains can affect the life quality. This study has performed in the first time in Mashhad.The purpose of the present study was to examine the effect of acupuncture on the life quality of 150 patients who suffered from chronic pain. Read more about this study
- Who is it for?
- Ages 17 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain
- What is being tested?
- acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteIran
- Study dates
- Jan 2009to Jan 2010
- Phase
- Phase 2/3
- 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 17 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- aged between 17 - 75 years old,
- suffering from arthritis pains,
- migraine backaches,
- muscular spasms,
- pains in the neck, and in the knee
- duration of disease over 1 year
Who cannot join
- tacking pain relief
- pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Islamic Azad University and Dr Sadre Nabavi Clinic
Chronic pains can affect the life quality. This study has performed in the first time in Mashhad.The purpose of the present study was to examine the effect of acupuncture on the life quality of 150 patients who suffered from chronic pain. Some people like performing acupuncture because they believed it's free of risks and beneficial.
In order to achieve this purpose, we had examined the life quality of the patients before and after acupuncture. This study was randomly performed on 150 patients aged between 17-75. They were suffering from chronic pain.
The questionnaire is based on WHO QOL. The questionnaires were filled out once before acupuncture and once 12 weeks after it.
Read the detailed description
This study was completed on time.
- Conditions
- Chronic Pain
- Being tested
- acupuncture
- Keywords
- Acupuncture, quality of life
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureProcedure or surgery
The patients went through acupuncture for 8 -10 sessions and either once or two times a week. The number and the place of needles were 8 -12 for each patient which were located on the right place.
| Study group | Role | What they receive |
|---|---|---|
| accupuncture, | Experimental | The patients went through acupuncture for 8 -10 sessions and either once or two times a week. The number and the place of needles were 8 -12 for each patient which were located on the right place. Receives: Procedure: acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of life improvement
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2012 (estimated)
- Study startJan 2009
- Primary completionAug 2009
- Study completionJan 2010
Why it stopped: This study was completed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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 2/3
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Islamic Azad University, Sanandaj
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tahereh Fathi Najafi, Islamic Azad University, Sanandaj
- Investigators
- Shahinfar medical university Fathi Najafi, phD student, Study director, IAUM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01651338
- Sponsor's protocol ID
- accupuncture
- Other IDs
- iaum
- Status last verified
- Jul 2012
- First submitted
- 17 Jul 2012
- Last updated
- 27 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Islamic Azad University and Dr Sadre Nabavi Clinic
- ClinicalTrials.gov ID
- NCT01651338
- Acronym / sponsor ID
- accupuncture
- Conditions
- Chronic Pain
- Keywords
- Acupuncture, quality of life
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was completed.
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Islamic Azad University, SanandajUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 27 Jul 2012 (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.
Chronic pains can affect the life quality. This study has performed in the first time in Mashhad.The purpose of the present study was to examine the effect of acupuncture on the life quality of 150 patients who suffered from chronic pain. Some people like performing acupuncture because they believed it's free of risks and beneficial.
In order to achieve this purpose, we had examined the life quality of the patients before and after acupuncture. This study was randomly performed on 150 patients aged between 17-75. They were suffering from chronic pain.
The questionnaire is based on WHO QOL. The questionnaires were filled out once before acupuncture and once 12 weeks after it.
Detailed description
This study was completed on time.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| accupuncture, | Experimental | Procedure: acupunctureThe patients went through acupuncture for 8 -10 sessions and either once or two times a week. The number and the place of needles were 8 -12 for each patient which were located on the right place. |
Who may qualify
- Ages
- 17 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- aged between 17 - 75 years old,
- suffering from arthritis pains,
- migraine backaches,
- muscular spasms,
- pains in the neck, and in the knee
Key exclusion criteria (2 listed)
- tacking pain relief
- pregnant women
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 |
|---|---|---|
| acupunctureThe patients went through acupuncture for 8 -10 sessions and either once or two times a week. The number and the place of needles were 8 -12 for each patient which were located on the right place. | Procedure or surgery | accupuncture, |
Primary outcome
quality of life improvement
Time frame: up to 3 months
Results and safety
The study was stopped early (reason given: This study was completed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2012.
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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.
Shahinfar medical university Fathi Najafi, phD student study director
IAUM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing acupuncture in people with Chronic Pain, run by Islamic Azad University, Sanandaj at 1 site in Iran.
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 6 inclusion and 2 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: stopped early, as of the sponsor's last update on 27 Jul 2012. 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 Iran. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: This study was completed.). Results are not available in the source record.
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?
quality of life improvement (time frame: up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jul 2012.