Chronic Low-back PainNCT05232487
Comparison of Swiss Versus Standard Low Back Acupuncture in Patients With Chronic Low Back Pain
A study testing Swiss low back acupuncture (SLBA) and Standard acupuncture (SA) in people with Chronic Low-back Pain, run by Li Yiming at 1 site in Switzerland.
Trial summary
Low back pain (LBP) is very common, widespread, and represents a multidimensional syndrome. It affects physical activity and function, health-related quality of life, and employment status. The lifetime prevalence of acute low back pain is approximately 80%. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- Swiss low back acupuncture (SLBA) and Standard acupuncture (SA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2023to Jul 2025
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female and male participants;
- Age between 18 and 75 years;
- Clinical diagnosis of CLBP with a disease duration of more than 3 months and an average pain intensity of minimally 4 points on a 11-point pain-numerical rating scale (pain-NRS) on the previous 7 days;
- Sufficient knowledge of German to complete the questionnaires.
Who cannot join
- All participants who do not meet the above-mentioned inclusion criteria;
- History or known severe concomitant diseases (e.g. abdominal aortic aneurysm, heart disease, cancer, psychiatric disorders).
- Other causes of low back pain not related to the clinical diagnosis of CLBP including inflammatory, malignant, or autoimmune disease;
- Planned or previous back surgery within 6 months
- Use of corticosteroids and/or other pain-relieving drugs that act through the central nervous system;
- Initiation of another therapy for CLBP within the last 4 weeks, e.g. physiotherapy;
Show all 9Show fewer
- Preceding acupuncture treatment for CLBP during the past 6 months;
- Pregnancy;
- Participation in another clinical trial.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Swiss TCM UNI
Bad Zurzach, Canton of Aargau, 5330
Michael Furian, Phd, +41 78 209 81 42, michael.furian@tcmuni.ch
About this study
Official title: Comparison of Swiss Versus Standard Low Back Acupuncture in Patients With Chronic Low Back Pain. A Randomized, Controlled, Single-blind, Monocentric Clinical Study
Low back pain (LBP) is very common, widespread, and represents a multidimensional syndrome. It affects physical activity and function, health-related quality of life, and employment status. The lifetime prevalence of acute low back pain is approximately 80%. The prevalence of chronic low back pain (CLBP) in the general population is reported to be 8% to 21%. Several clinical trials have provided evidence to support the efficacy of acupuncture in the treatment of LBP, however, the optimal acupuncture treatment for CLBP has not been extensively studied.
Read the detailed description
Low back pain (LBP) is a common, widespread and multifaceted syndrome and represents one of the leading sources of years lived with disability. In Switzerland, patients with LBP generated mean annual costs of 467 million Euro in 2016 and 2017, respectively. Moreover, quantity of prescriptions per patient was reported to be 5 - 6 per year, causing pain medication costs of 4.7 million Euro. It is estimated that 20% of acute LBP can manifest as chronic LBP (CLBP), defined as pain lasting longer than three months. CLBP does not only negatively impact the quality of life, functional status, and working capability of those suffering, but also plays a pivotal role of the large annual health care costs for LBP in Switzerland and worldwide. Pharmacological therapies with at least a small magnitude of effect for pain relief in CLBP include non-steroidal anti-inflammatory drugs, opioids, Tramadol and antidepressants. Additionally, non-pharmacological therapies with at least a small magnitude of effect for pain relief in CLBP include exercise, motor control exercise, Yoga, mindfulness-based stress reduction, electromyography biofeedback, cognitive-behavioral therapy, multidisciplinary rehabilitation and acupuncture.
In this context and during the last decades and centuries, different acupuncture methods evolved, among others, the acupuncture method newly termed "Swiss low back acupuncture" (SLBA). The SLBA originates from Jiu Gong Points (九宫穴), which is the abbreviation for "Nine Spinal Points" (脊椎九宫穴). The particular sites of Jiu Gong Points were evolved from the eight trigrams and nine palaces square (Ba Gua Jiu Gong fang 八卦九宫方). The eight trigrams (Ba Gua 八卦) are a set of metaphysical and philosophical sigmas composed of three components of yin and yang, which are the essential concept of all-natural phenomena. Nine palaces (Jiu Gong, 九宫), an element of the eight trigrams, correspond to the nine regions in ancient China (Jiu Ye, 九野). They represent the four main (North=kidney; South=heart; East=liver; West=lung; Earth=spleen) and four secondary cardinal points and the earth as the center. In 825 patients with LBP due to lumbar herniated disc, it has been shown that hot needle acupuncture (热针) using Jiu Gong Points around the most significant lesion of the lumbar vertebrae results in good improvements of pain. The uncontrolled study reported a cure of LBP in 65.2% of cases and an improvement of clinical symptoms of 32.4%. Due to the positive report, the hot needle acupuncture using Jiu Gong Points has further evolved in Switzerland and might be a promising tool to treat CLBP, since the optimal method of acupuncture against CLBP remains to be elucidated. However, the efficacy of SLBA has never been quantitatively compared to SA and a randomized clinical trial is warranted to provide first robust evidence on its performance in CLBP.
Therefore, the purpose of this study is to conduct the first randomized clinical trial comparing SLBA and SA on pain relief in patients with CLBP.
- Conditions
- Chronic Low-back Pain
- Being tested
- Swiss low back acupuncture (SLBA), Standard acupuncture (SA)
- Keywords
- chronic low back pain, Acupuncture, Standard acupuncture, Swiss low back acupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swiss low back acupuncture (SLBA)Other
Participants are placed in the prone position (if required with a pillow under the abdomen). Then acupuncture is applied to the back of the body. The treatment takes place for the duration of 9 weeks (2x per week from week 1 to 6 and 1x a week from week 7 to 9). One treatment session lasts about 50-60 minutes.
Swiss low back pain acupuncture The SLBA method is a further developed method from the Jiu Gong acupuncture technique, also known as the Nine Palace-Points on the spine. The following acupuncture points will be used: LV3/ LV5, Tai Xi (Kl 3), Fe Yang (BL 58), Tai Chong (LR 3), Guang Ming (GB 37), Tai Xi (Kl 3) and Fe Yang (BL 58).
Standard acupuncture (SA)Other
Participants are placed in the prone position (if required with a pillow under the abdomen). Then acupuncture is applied to the back of the body. The treatment takes place for the duration of 9 weeks (2x per week from week 1 to 6 and 1x a week from week 7 to 9). One treatment session lasts about 50-60 minutes. The SA method is described in the acupuncture textbook for TCM in China and all acupuncture points are selected based on TCM principles, international literature, and the opinion of national and international TCM experts. The following points have been selected: Ming Men (GV 4), Zhi Shi (BL 52), Tai Xi (KI 3) Yao Guan (GV 3), Guan Yuan Shu (BL 26), Ge Shu (BL 17), Ci Liao (BL 32), Wei Zhong (BL 40), Ji Zhong (GV 6), Yao Yang Guan (GV 3), Shen Shu (BL 23), Da Chang Shu (BL 25) and A-Shi points.
| Study group | Role | What they receive |
|---|---|---|
| Swiss low back acupuncture group | Experimental | Participants in this group will be treated with the Swiss low back acupuncture method. Receives: Other: Swiss low back acupuncture (SLBA) |
| Standard acupuncture group | Active comparator | Participants in this group will be treated with the standard acupuncture method. Receives: Other: Standard acupuncture (SA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Severeity rated by 11-Point Numerical Rating Scale
Pain severity will be assessed by the 11-point numerical rating scale, ranging from 0 "No pain" to 10 "maximal pain".
Measured: Difference in change between 9 weeks of treatment with SLBA compared to SA therapy.
Secondary outcomes (5)
Changes in biopsychosocial health and quality of life
The Short Form 36 will be assessed at the start of the intervention (T1) and after completion of the last intervention (T2), as well as at follow-up (3 months after the end of intervention [T3] / 6 months after the end of intervention [T4]).
Measured: Difference in change between 9 weeks of treatment with SLBA compared to SA therapy; after 3 and 6 months follow-up.
Changes in symptomatic distress
The SCL-90 R. Scales of Anxiety (10 items), Depression (13 items), and Somatization (12 items) will be assessed at the start of the intervention (T1) and after completion of the last intervention (T2), as well as at follow-up (3 months after the end of intervention [T3] / 6 months after the end of intervention [T4]).
Measured: Difference in change between 9 weeks of treatment with SLBA compared to SA therapy; after 3 and 6 months follow-up.
Changes in functional status and disability
The score of the Oswestry Disability Index will be assessed at the start of the intervention (T1) and after completion of the last intervention (T2), as well as at follow-up (3 months after the end of intervention [T3] / 6 months after the end of intervention [T4]).
Measured: Difference in change between 9 weeks of treatment with SLBA compared to SA therapy; after 3 and 6 months follow-up.
Multidimensional Pain Inventory (MPI) - pain severity score
Pain severity score will be calculated from 3 items:
- Rate the severity of your current pain (now, at the moment).
- How severe was your pain in the last week? (average)
- How much do you suffer from your pain?
The total score will be transformed into 0 (maximal pain) to 100 points (no pain) by the following equation: 100 - (scored points)/18 ×100
MPI will be assessed at the start of the intervention (T1) and after completion of the last intervention (T2), as well as at follow-up (3 months after the end of intervention [T3] / 6 months after the end of intervention [T4]).
Measured: Difference in change between 9 weeks of treatment with SLBA compared to SA therapy.
Pain diary
Patients will be asked to complete a daily pain diary during the 9-weeks of acupuncture therapy (completed at the end of each day, before going to bed). In this diary, the patients will rate their perceived pain severity from 0 (none) to 5 (almost intolerable pain) during pre-defined periods of the day. Furthermore, drug intake related to pain relief will be documented.
Measured: During the 9 weeks of treatment with SLBA compared to SA therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study startJan 2023 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Chronic Low-back 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
- Model description
- This study is a randomized, controlled, single-blind, parallel trial, allocating patients with CLBP 1:1 to either 9 weeks of SLBA or SA therapy.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Li Yiming
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss University for Traditional Chinese Medicine
- Responsible party
- Sponsor-investigator, Li Yiming, TCM Ming Dao
- Investigators
- Michael Furain, PhD, Principal investigator, Swiss University for Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05232487
- Sponsor's protocol ID
- Study ID: TCM_AKU01/2021
- Status last verified
- Dec 2022
- First submitted
- 30 Dec 2021
- Last updated
- 15 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained through this study may be provided to qualified researchers with an academic interest in LBP. Data or samples shared will be coded, with no Protected Health Information included. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party.
Publications
Angst F, Verra ML, Lehmann S, Aeschlimann A. Responsiveness of five condition-specific and generic outcome assessment instruments for chronic pain. BMC Med Res Methodol. 2008 Apr 25;8:26. doi: 10.1186/1471-2288-8-26.
PubMed 18439285Angst F, Verra ML, Lehmann S, Aeschlimann A, Angst J. Refined insights into the pain-depression association in chronic pain patients. Clin J Pain. 2008 Nov-Dec;24(9):808-16. doi: 10.1097/AJP.0b013e31817bcc5f.
PubMed 18936599Benz T, Lehmann S, Elfering A, Sandor PS, Angst F. Comprehensiveness and validity of a multidimensional assessment in patients with chronic low back pain: a prospective cohort study. BMC Musculoskelet Disord. 2021 Mar 20;22(1):291. doi: 10.1186/s12891-021-04130-x.
PubMed 33743669Chan MWC, Wu XY, Wu JCY, Wong SYS, Chung VCH. Safety of Acupuncture: Overview of Systematic Reviews. Sci Rep. 2017 Jun 13;7(1):3369. doi: 10.1038/s41598-017-03272-0.
PubMed 28611366Hasenbring, M. (2004). Rückenschmerzen: Der Chronifizierung frühzeitig entgegenwirken. In Neuroorthopädie (pp. 13-21). Steinkopff. https://doi.org/10.1007/978-3-7985-1949-7_3
Kim J, Shin W. How to do random allocation (randomization). Clin Orthop Surg. 2014 Mar;6(1):103-9. doi: 10.4055/cios.2014.6.1.103. Epub 2014 Feb 14.
PubMed 24605197Labots G, Jones A, de Visser SJ, Rissmann R, Burggraaf J. Gender differences in clinical registration trials: is there a real problem? Br J Clin Pharmacol. 2018 Apr;84(4):700-707. doi: 10.1111/bcp.13497. Epub 2018 Feb 12.
PubMed 29293280Lee CP, Fu TS, Liu CY, Hung CI. Psychometric evaluation of the Oswestry Disability Index in patients with chronic low back pain: factor and Mokken analyses. Health Qual Life Outcomes. 2017 Oct 3;15(1):192. doi: 10.1186/s12955-017-0768-8.
PubMed 28974227Leem J. Does acupuncture increase the risk of bleeding in patients taking warfarin? Integr Med Res. 2015 Jun;4(2):119-121. doi: 10.1016/j.imr.2015.04.001. Epub 2015 Apr 22. No abstract available.
PubMed 28664117Mcculloch M, Nachat A, Schwartz J, Casella-Gordon V, Cook J. Acupuncture safety in patients receiving anticoagulants: a systematic review. Perm J. 2015 Winter;19(1):68-73. doi: 10.7812/TPP/14-057. Epub 2014 Nov 24.
PubMed 25432001Mu J, Furlan AD, Lam WY, Hsu MY, Ning Z, Lao L. Acupuncture for chronic nonspecific low back pain. Cochrane Database Syst Rev. 2020 Dec 11;12(12):CD013814. doi: 10.1002/14651858.CD013814.
PubMed 33306198Pignon JP, Arriagada R. Early stopping rules and long-term follow-up in phase III trials. Lung Cancer. 1994 Mar;10 Suppl 1:S151-9. doi: 10.1016/0169-5002(94)91677-2.
PubMed 8087505Salaffi F, Stancati A, Silvestri CA, Ciapetti A, Grassi W. Minimal clinically important changes in chronic musculoskeletal pain intensity measured on a numerical rating scale. Eur J Pain. 2004 Aug;8(4):283-91. doi: 10.1016/j.ejpain.2003.09.004.
PubMed 15207508Schmitz N, Hartkamp N, Kiuse J, Franke GH, Reister G, Tress W. The Symptom Check-List-90-R (SCL-90-R): a German validation study. Qual Life Res. 2000 Mar;9(2):185-93. doi: 10.1023/a:1008931926181.
PubMed 10983482Witt CM, Pach D, Brinkhaus B, Wruck K, Tag B, Mank S, Willich SN. Safety of acupuncture: results of a prospective observational study with 229,230 patients and introduction of a medical information and consent form. Forsch Komplementmed. 2009 Apr;16(2):91-7. doi: 10.1159/000209315. Epub 2009 Apr 9.
PubMed 19420954
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Swiss Versus Standard Low Back Acupuncture in Patients With Chronic Low Back Pain. A Randomized, Controlled, Single-blind, Monocentric Clinical Study
- ClinicalTrials.gov ID
- NCT05232487
- Acronym / sponsor ID
- Study ID: TCM_AKU01/2021
- Conditions
- Chronic Low-back Pain
- Keywords
- chronic low back pain, Acupuncture, Standard acupuncture, Swiss low back acupuncture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Li YimingUniversity, hospital or other
- Collaborators
- Swiss University for Traditional Chinese Medicine
- Study start
- Jan 2023 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 9 Feb 2022 (actual)
- 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.
Low back pain (LBP) is very common, widespread, and represents a multidimensional syndrome. It affects physical activity and function, health-related quality of life, and employment status. The lifetime prevalence of acute low back pain is approximately 80%. The prevalence of chronic low back pain (CLBP) in the general population is reported to be 8% to 21%. Several clinical trials have provided evidence to support the efficacy of acupuncture in the treatment of LBP, however, the optimal acupuncture treatment for CLBP has not been extensively studied.
Detailed description
Low back pain (LBP) is a common, widespread and multifaceted syndrome and represents one of the leading sources of years lived with disability. In Switzerland, patients with LBP generated mean annual costs of 467 million Euro in 2016 and 2017, respectively. Moreover, quantity of prescriptions per patient was reported to be 5 - 6 per year, causing pain medication costs of 4.7 million Euro. It is estimated that 20% of acute LBP can manifest as chronic LBP (CLBP), defined as pain lasting longer than three months. CLBP does not only negatively impact the quality of life, functional status, and working capability of those suffering, but also plays a pivotal role of the large annual health care costs for LBP in Switzerland and worldwide. Pharmacological therapies with at least a small magnitude of effect for pain relief in CLBP include non-steroidal anti-inflammatory drugs, opioids, Tramadol and antidepressants. Additionally, non-pharmacological therapies with at least a small magnitude of effect for pain relief in CLBP include exercise, motor control exercise, Yoga, mindfulness-based stress reduction, electromyography biofeedback, cognitive-behavioral therapy, multidisciplinary rehabilitation and acupuncture.
In this context and during the last decades and centuries, different acupuncture methods evolved, among others, the acupuncture method newly termed "Swiss low back acupuncture" (SLBA). The SLBA originates from Jiu Gong Points (九宫穴), which is the abbreviation for "Nine Spinal Points" (脊椎九宫穴). The particular sites of Jiu Gong Points were evolved from the eight trigrams and nine palaces square (Ba Gua Jiu Gong fang 八卦九宫方). The eight trigrams (Ba Gua 八卦) are a set of metaphysical and philosophical sigmas composed of three components of yin and yang, which are the essential concept of all-natural phenomena. Nine palaces (Jiu Gong, 九宫), an element of the eight trigrams, correspond to the nine regions in ancient China (Jiu Ye, 九野). They represent the four main (North=kidney; South=heart; East=liver; West=lung; Earth=spleen) and four secondary cardinal points and the earth as the center. In 825 patients with LBP due to lumbar herniated disc, it has been shown that hot needle acupuncture (热针) using Jiu Gong Points around the most significant lesion of the lumbar vertebrae results in good improvements of pain. The uncontrolled study reported a cure of LBP in 65.2% of cases and an improvement of clinical symptoms of 32.4%. Due to the positive report, the hot needle acupuncture using Jiu Gong Points has further evolved in Switzerland and might be a promising tool to treat CLBP, since the optimal method of acupuncture against CLBP remains to be elucidated. However, the efficacy of SLBA has never been quantitatively compared to SA and a randomized clinical trial is warranted to provide first robust evidence on its performance in CLBP.
Therefore, the purpose of this study is to conduct the first randomized clinical trial comparing SLBA and SA on pain relief in patients with CLBP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a randomized, controlled, single-blind, parallel trial, allocating patients with CLBP 1:1 to either 9 weeks of SLBA or SA therapy.
| Arm | Type | Receives |
|---|---|---|
| Swiss low back acupuncture group | Experimental | Other: Swiss low back acupuncture (SLBA)Participants in this group will be treated with the Swiss low back acupuncture method. |
| Standard acupuncture group | Active comparator | Other: Standard acupuncture (SA)Participants in this group will be treated with the standard acupuncture method. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female and male participants;
- Age between 18 and 75 years;
- Clinical diagnosis of CLBP with a disease duration of more than 3 months and an average pain intensity of minimally 4 points on a 11-point pain-numerical rating scale (pain-NRS) on the previous 7 days;
- Sufficient knowledge of German to complete the questionnaires.
Key exclusion criteria (9 listed)
- All participants who do not meet the above-mentioned inclusion criteria;
- History or known severe concomitant diseases (e.g. abdominal aortic aneurysm, heart disease, cancer, psychiatric disorders).
- Other causes of low back pain not related to the clinical diagnosis of CLBP including inflammatory, malignant, or autoimmune disease;
- Planned or previous back surgery within 6 months
- Use of corticosteroids and/or other pain-relieving drugs that act through the central nervous system;
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 |
|---|---|---|
| Swiss low back acupuncture (SLBA)Participants are placed in the prone position (if required with a pillow under the abdomen). Then acupuncture is applied to the back of the body. The treatment takes place for the duration of 9 weeks (2x per week from week 1 to 6 and 1x a week from week 7 to 9). One treatment session lasts about 50-60 minutes. Swiss low back pain acupuncture The SLBA method is a further developed method from the Jiu Gong acupuncture technique, also known as the Nine Palace-Points on the spine. The following acupuncture points will be used: LV3/ LV5, Tai Xi (Kl 3), Fe Yang (BL 58), Tai Chong (LR 3), Guang Ming (GB 37), Tai Xi (Kl 3) and Fe Yang (BL 58). | Other | Swiss low back acupuncture group |
| Standard acupuncture (SA)Participants are placed in the prone position (if required with a pillow under the abdomen). Then acupuncture is applied to the back of the body. The treatment takes place for the duration of 9 weeks (2x per week from week 1 to 6 and 1x a week from week 7 to 9). One treatment session lasts about 50-60 minutes. The SA method is described in the acupuncture textbook for TCM in China and all acupuncture points are selected based on TCM principles, international literature, and the opinion of national and international TCM experts. The following points have been selected: Ming Men (GV 4), Zhi Shi (BL 52), Tai Xi (KI 3) Yao Guan (GV 3), Guan Yuan Shu (BL 26), Ge Shu (BL 17), Ci Liao (BL 32), Wei Zhong (BL 40), Ji Zhong (GV 6), Yao Yang Guan (GV 3), Shen Shu (BL 23), Da Chang Shu (BL 25) and A-Shi points. | Other | Standard acupuncture group |
Primary outcome
Pain Severeity rated by 11-Point Numerical Rating Scale
Time frame: Difference in change between 9 weeks of treatment with SLBA compared to SA therapy.
Pain severity will be assessed by the 11-point numerical rating scale, ranging from 0 "No pain" to 10 "maximal pain".
5 secondary outcomes
Changes in biopsychosocial health and quality of life
Time frame: Difference in change between 9 weeks of treatment with SLBA compared to SA therapy; after 3 and 6 months follow-up.
Changes in symptomatic distress
Time frame: Difference in change between 9 weeks of treatment with SLBA compared to SA therapy; after 3 and 6 months follow-up.
Changes in functional status and disability
Time frame: Difference in change between 9 weeks of treatment with SLBA compared to SA therapy; after 3 and 6 months follow-up.
Multidimensional Pain Inventory (MPI) - pain severity score
Time frame: Difference in change between 9 weeks of treatment with SLBA compared to SA therapy.
Pain diary
Time frame: During the 9 weeks of treatment with SLBA compared to SA therapy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2022.
- Background: PubMed 18439285Angst F, Verra ML, Lehmann S, Aeschlimann A. Responsiveness of five condition-specific and generic outcome assessment instruments for chronic pain. BMC Med Res Methodol. 2008 Apr 25;8:26. doi: 10.1186/1471-2288-8-26.
- Background: PubMed 18936599Angst F, Verra ML, Lehmann S, Aeschlimann A, Angst J. Refined insights into the pain-depression association in chronic pain patients. Clin J Pain. 2008 Nov-Dec;24(9):808-16. doi: 10.1097/AJP.0b013e31817bcc5f.
- Background: PubMed 33743669Benz T, Lehmann S, Elfering A, Sandor PS, Angst F. Comprehensiveness and validity of a multidimensional assessment in patients with chronic low back pain: a prospective cohort study. BMC Musculoskelet Disord. 2021 Mar 20;22(1):291. doi: 10.1186/s12891-021-04130-x.
- Background: PubMed 28611366Chan MWC, Wu XY, Wu JCY, Wong SYS, Chung VCH. Safety of Acupuncture: Overview of Systematic Reviews. Sci Rep. 2017 Jun 13;7(1):3369. doi: 10.1038/s41598-017-03272-0.
- BackgroundHasenbring, M. (2004). Rückenschmerzen: Der Chronifizierung frühzeitig entgegenwirken. In Neuroorthopädie (pp. 13-21). Steinkopff. https://doi.org/10.1007/978-3-7985-1949-7_3
- Background: PubMed 24605197Kim J, Shin W. How to do random allocation (randomization). Clin Orthop Surg. 2014 Mar;6(1):103-9. doi: 10.4055/cios.2014.6.1.103. Epub 2014 Feb 14.
- Background: PubMed 29293280Labots G, Jones A, de Visser SJ, Rissmann R, Burggraaf J. Gender differences in clinical registration trials: is there a real problem? Br J Clin Pharmacol. 2018 Apr;84(4):700-707. doi: 10.1111/bcp.13497. Epub 2018 Feb 12.
- Background: PubMed 28974227Lee CP, Fu TS, Liu CY, Hung CI. Psychometric evaluation of the Oswestry Disability Index in patients with chronic low back pain: factor and Mokken analyses. Health Qual Life Outcomes. 2017 Oct 3;15(1):192. doi: 10.1186/s12955-017-0768-8.
- Background: PubMed 28664117Leem J. Does acupuncture increase the risk of bleeding in patients taking warfarin? Integr Med Res. 2015 Jun;4(2):119-121. doi: 10.1016/j.imr.2015.04.001. Epub 2015 Apr 22. No abstract available.
- Background: PubMed 25432001Mcculloch M, Nachat A, Schwartz J, Casella-Gordon V, Cook J. Acupuncture safety in patients receiving anticoagulants: a systematic review. Perm J. 2015 Winter;19(1):68-73. doi: 10.7812/TPP/14-057. Epub 2014 Nov 24.
- Background: PubMed 33306198Mu J, Furlan AD, Lam WY, Hsu MY, Ning Z, Lao L. Acupuncture for chronic nonspecific low back pain. Cochrane Database Syst Rev. 2020 Dec 11;12(12):CD013814. doi: 10.1002/14651858.CD013814.
- Background: PubMed 8087505Pignon JP, Arriagada R. Early stopping rules and long-term follow-up in phase III trials. Lung Cancer. 1994 Mar;10 Suppl 1:S151-9. doi: 10.1016/0169-5002(94)91677-2.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers with an academic interest in LBP. Data or samples shared will be coded, with no Protected Health Information included. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party.
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Osteoarthritis, Knee, Diabetic Neuropathic Pain
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.
Michael Furain, PhD principal investigator
Swiss University for Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Swiss low back acupuncture (SLBA) and Standard acupuncture (SA) in people with Chronic Low-back Pain, run by Li Yiming at 1 site in Switzerland.
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 9 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: status not confirmed, as of the sponsor's last update on 15 Dec 2022. 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 Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Furian, PhD (+ 41 079 403 75 86, michael.furian@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Severeity rated by 11-Point Numerical Rating Scale (time frame: Difference in change between 9 weeks of treatment with SLBA compared to SA therapy.). 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 NCT05232487, which also lists 19 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 15 Dec 2022.