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Trial registered on ANZCTR


Registration number
ACTRN12609000698279
Ethics application status
Approved
Date submitted
9/08/2009
Date registered
12/08/2009
Date last updated
12/08/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Acupuncture in Chronic Lower Back Pain
Scientific title
Acupuncture and the effect of Baclofen on chronic lower back pain in older patients
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
non-specific low back pain 243487 0
Condition category
Condition code
Alternative and Complementary Medicine 239787 239787 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
acupuncture treatment for chronic low back pain orally baclofen administration.The enrolled subjects randomly were divided to: (1) control (C) group,(2) acupuncture treated (AC) group,(3) baclofen treated (BA) group, and(4) acupuncture plus baclofen treated (BA+AC) group. Treatment procedures for all groups were continued for 5 weeks, which is a standard frequency of treatments for chronic pain .
(2)Acupuncture (AC) group:
Acupuncture treatment followed the Standard Recommendation in Clinical Trial of Acupuncture (STRICTA) (18). Subjects in this group received acupuncture treatment 2 times a week for 5 weeks by certified acupuncturist. Acupuncture protocol followed the modern approach to acupuncture which incorporates neurohumoral theories of acupuncture treatment mechanism. Each patient, according to major acupuncture references, received needle in following selected acupoints: Shenshu (BL23), Dachangshu (BL25), Panguanshu (BL28) Ciliao (BL32), Kunlum (BL60), huantiao(GB30) and Yanglingquan (GB 34). Aseptic procedure and disposable, stainless, 30- gauge needles with electrical stimulation at 4-6 Hz with pulse duration of 0.5 ms were used (28, 29). Needles (0.2 mm × 40 mm, Seirin Co Ltd) were inserted into the acupoints till the subject felt dull pain or de qi. At each session 10-12 needles were used and needles were left in place for 20-25 minutes.

(3)Baclofen (BA) group:
The 30 mg/day orally administered dose of baclofen is recommended as effective dose in chronic LBP. It is also known that at this dose required for pain relief, no motor impairment was observed (24).

(4)Acupuncture plus baclofen treated (BA+AC) group:
These patients in A+B treated group received both baclofen (30 mg/day, orally) and, 2 times a week, 20-25 min acupuncture treatment (according to acupuncture method which mentioned above) for 5 weeks.
Intervention code [1] 237105 0
Treatment: Other
Intervention code [2] 237106 0
Treatment: Drugs
Comparator / control treatment
(1)Control (C) group:
The control group did not receive any specific treatment for chronic pain and followed their normal life style. These patients asked to remain on their same life and not start new medications.
Control group
Active

Outcomes
Primary outcome [1] 240555 0
pain intensity, which quantified with a 10 cm visual analogue scale (VAS, 0-100 mm)
Timepoint [1] 240555 0
The VAS scores were measured immediately before the first treatment and subsequently at one, two,
three, four, five and ten weeks after the first treatment.
Primary outcome [2] 240556 0
self-reported pain disability, which assessed with Roland Morris Questionnaire (RDQ, 0-24 points).
Timepoint [2] 240556 0
The RDQ scores were measured immediately before the first treatment and subsequently five and ten weeks after the first treatment.
Secondary outcome [1] 257143 0
Nil
Timepoint [1] 257143 0
Nil

Eligibility
Key inclusion criteria
(1) lumbar or lumbosacral pain for six months or longer; (2) no radiation of
low back pain to other regions; (3) normal neurological signs of lumbosacral nerve
including: deep tendon and plantar reflexes, voluntary muscle activities, straight leg raising, and sensory functions; and (4) not receiving any other treatments for more than 3 months before beginning the study.
Minimum age
50 Years
Maximum age
60 Years
Gender
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
(1) major trauma or systemic disorders; (2) receiving conflicting or ongoing co-interventions; (3) the prior use of acupuncture for Low Back Pain(LBP); and (4) refusal to be randomized

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)
Men with non- specific LBP, aged 50-60 years were recruited from the Tehran
University Medical Science (TUMS).Participants were randomized to one of the four groups, using a stratified blocked randomization scheme and statistical software for random deviate generation. The enrolled subjects randomly were divided to: control (C) group, acupuncture treated (AC) group, baclofen treated (BA) group, and acupuncture plus baclofen treated (BA+AC) group. Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants were randomized to one of the four groups, using a stratified blocked
randomization scheme and statistical software for random deviate generation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 1943 0
Iran, Islamic Republic Of
State/province [1] 1943 0

Funding & Sponsors
Funding source category [1] 237478 0
University
Name [1] 237478 0
Tehran medical university
Address [1] 237478 0
Tehran medical university, EnghelabSt, Tehran.
area code: 021
Country [1] 237478 0
Iran, Islamic Republic Of
Funding source category [2] 237479 0
Self funded/Unfunded
Name [2] 237479 0
Jalal Zaringhalam
Address [2] 237479 0
Physiology Dep, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
area code: 021
Country [2] 237479 0
Iran, Islamic Republic Of
Primary sponsor type
Individual
Name
jalal zaringhalam
Address
Physiology Dep, Shahid Beheshti University of Medical Sciences,Tehran, Iran.
area code: 021
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 236963 0
None
Name [1] 236963 0
Address [1] 236963 0
Country [1] 236963 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239602 0
Tehran University of Medical Sciences (TUMS)
Ethics committee address [1] 239602 0
Tehran University of Medical Sciences, Enghleb St, Tehran
area code: 021
Ethics committee country [1] 239602 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 239602 0
Approval date [1] 239602 0
04/03/2006
Ethics approval number [1] 239602 0
2458

Summary
Brief summary
Chronic non- specific low back pain (LBP) is a prevailing and multidimensional
problem, which different treatment methods were applied. Methods: 84
patients (men, aged 40-65 years) with non-specific chronic LBP were randomly
allocated in four groups. The baclofen group received only orally administered
baclofen (30mg/day); the acupuncture group received only acupuncture treatment at
selected acupoints for chronic low back pain; the acupuncture + baclofen group
received both acupuncture and baclofen treatments; and the control group followed
normal life with no pain reducing interventions. Treatments were applied for five weeks and the results followed till 10th week of treatment. Outcome measures were pain intensity in terms of visual analogue scale (VAS) and self-reported pain disability in terms of Roland-Morris Disability Questionnaire (RDQ).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30030 0
Address 30030 0
Country 30030 0
Phone 30030 0
Fax 30030 0
Email 30030 0
Contact person for public queries
Name 13277 0
Jalal Zaringhalam
Address 13277 0
Physiology dep, Shahid Beheshti University Of Medical Sciences, Tehran, Iran.
area code: 021
Country 13277 0
Iran, Islamic Republic Of
Phone 13277 0
+98 912 516 8313
Fax 13277 0
+98 21 22439971
Email 13277 0
jzaringhalam@yahoo.com
Contact person for scientific queries
Name 4205 0
Jalal Zaringhalam
Address 4205 0
Physiology dep, Shahid Beheshti University Of Medical Sciences, Tehran, Iran.
area code: 021
Country 4205 0
Iran, Islamic Republic Of
Phone 4205 0
+98 912 516 8313
Fax 4205 0
+98 21 22439971
Email 4205 0
jzaringhalam@yahoo.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary