Impact of Muscle Degeneration in Chronic Low Back Pain

Back Pain Clinical Trial

Official title:

Impact of Muscle Degeneration in Chronic ow Back Pain in Patients Undergoing Neural Decompression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04273828
• Other study ID #: 94868618.7.0000.0071
• Status: Recruiting
• Start date: April 6, 2020
• Est. completion date: November 1, 2023

Study information

• Verified date: March 2021
• Source: Hospital Israelita Albert Einstein
• Contact: Alberto Gotfryd, PhD
• Phone: 5511995925225
• Email: albertocoluna[@]yahoo.com.br
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Surgical interventions for the removal of intervertebral disc fragments or to enlarge a narrow spine canal are commonly performed worldwide and are considered efficient. Concomitant low back pain is not uncommon among patients with lumbar nerve compression and neurological symptoms. When present, controversy persists in the literature regarding its ideal management. Although neurological symptoms improve after decompressive surgery, the presence of residual chronic low back pain may worsen satisfaction scores and cause functional disability.

The hypothesis of the present study is that the presence of atrophy of the paraspinal and trunk muscles predicts chronic low back pain after lumbar neural decompression. If confirmed, this finding will aid in better planning of physical rehabilitation strategies for this group of patients, as well as a clearer prediction regarding surgical treatment outcomes for patients and health professionals.

Description:

This is a prospective cohort study. Patients with lumbar degenerative diseases and symptoms of nerve compression (radiculopathy or neurogenic claudication) who will undergo surgical treatment for neural decompression (discectomy, foraminotomy or laminectomy).

The cohort will be followed by a team researcher (not blinded to the purpose of the study) at preoperative (up to 1 month before surgery), immediate postoperative (12 to 24 hours after procedure), 06, 12 and 24 months after surgery. Imaging tests will be performed on the preoperative evaluation and at six months follow-up after the operation.

The treatment will consist of lumbar decompression surgery, which may consist of discectomy, foraminotomy or laminectomy, according to the type and location of the compression. The choice of surgical technique will be made by the assistant surgeon.

Patients will be divided into four groups regarding the type of soft tissue retractor and image magnification:

Group 1: (minimally invasive microdiscectomy): surgeries performed with loupes or microscope plus minimally invasive soft tissue retractors (tubular or "Caspar").

Group 2: (open microdiscectomy) surgeries performed with loupes or microscope plus conventional soft tissue retractors (auto static, "Taylor" or "McCulloch").

Group 3: (endoscopic discectomy): surgeries performed by means of the "full endoscopic" technique;

Group 4: (open discectomy "with the naked eye"): surgeries performed without image magnification. Use of conventional soft tissue retractors (auto static, "Taylor" or "McCulloch").

Image Evaluation:

1. X-Rays (anteroposterior, lateral, dynamic lateral films) - to evaluate and measure the presence of scoliosis, spondylolisthesis or Degenerative vertebral dislocations.

2. MRI: to detect and to grade the presence of fat infiltration of the Psoas and Multifidus muscles (Arabanas et al); to grade Modic Signal and facet joint degeneration (Weishaupt et al).

Sample size:

For the sample size estimation, we considered the main outcome of the study, a 1.5-point change in the pain scale (VAS) among patients with fat infiltration (grades 1, 2, or 3) and without fat infiltration (grade 0), after 6 months of spine surgery, with 80% power and 95% confidence, the sample required for the study is 28 patients in each group considering a two-tailed test. Similarly to the previous study, we observed that the first 14 patients in the pilot study, 20% of patients had without fat infiltration, therefore, as the admission of patients into the study is consecutive, we expect to find this same percentage of patients without fat infiltration in the final sample of patients, so 140 patients are needed to get 28 patients without fat infiltration. Predicting a loss of 20% of patients at 6 months of follow-up, the initial sample to be considered will be 168 patients to obtain the minimum number of patients required in each group.

Statistics:

Numerical variables with normal distribution will be described by means and standard deviations and variables with non-normal distribution by medians and interquartile ranges, in addition to the minimum and maximum values. The distributions of numerical variables will be verified by histograms, boxplots, and, if necessary, Shapiro-Wilk normality tests. Categorical variables will be described by absolute frequencies and percentages. The analyzes will be performed with the SPSS26 program, considering a 5% significance level.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 168
• Est. completion date: November 1, 2023
• Est. primary completion date: December 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. adults 18 years of age and older;

2. with symptoms of lumbosacral neural compression (radiculopathy or neurogenic lameness);

3. failed conservative treatment for at least 6 weeks;

4. undergoing surgery for neural decompression (discectomy and / or foraminotomy and / or hemilaminectomy);

5. with complete pre and postoperative medical records in all evaluations.

Exclusion Criteria:

1. need for lumbar arthrodesis;

2. deep infection requiring surgical cleaning;

3. patients submitted to joint facet rhizotomy;

4. active rheumatologic disease, including seronegative arthropathies.

Related Conditions & MeSH terms

• Back Pain
• Hernia
• Lumbar Disc Herniation
• Lumbar Spinal Stenosis
• Radiculopathy
• Spinal Stenosis

Intervention

Procedure:
• Lumbar decompressive surgery
Patients with lumbar degenerative diseases and symptoms of nerve compression (radiculopathy or neurogenic claudication) who will undergo surgical treatment for neural decompression (discectomy, foraminotomy or laminectomy).

Locations

Country	Name	City	State
Brazil	Hospital Israelita Albert Einstein	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Israelita Albert Einstein

Country where clinical trial is conducted

Brazil, 

References & Publications (22)

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Abreu AM, Faria CD, Cardoso SM, Teixeira-Salmela LF. [The Brazilian version of the Fear Avoidance Beliefs Questionnaire]. Cad Saude Publica. 2008 Mar;24(3):615-23. Portuguese. — View Citation

Arbanas J, Pavlovic I, Marijancic V, Vlahovic H, Starcevic-Klasan G, Peharec S, Bajek S, Miletic D, Malnar D. MRI features of the psoas major muscle in patients with low back pain. Eur Spine J. 2013 Sep;22(9):1965-71. doi: 10.1007/s00586-013-2749-x. Epub 2013 Mar 31. — View Citation

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Bydon M, De la Garza-Ramos R, Macki M, Baker A, Gokaslan AK, Bydon A. Lumbar fusion versus nonoperative management for treatment of discogenic low back pain: a systematic review and meta-analysis of randomized controlled trials. J Spinal Disord Tech. 2014 Jul;27(5):297-304. doi: 10.1097/BSD.0000000000000072. Review. — View Citation

Costa LO, Maher CG, Latimer J, Ferreira PH, Ferreira ML, Pozzi GC, Freitas LM. Clinimetric testing of three self-report outcome measures for low back pain patients in Brazil: which one is the best? Spine (Phila Pa 1976). 2008 Oct 15;33(22):2459-63. doi: 10.1097/BRS.0b013e3181849dbe. — View Citation

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Järvinen J, Karppinen J, Niinimäki J, Haapea M, Grönblad M, Luoma K, Rinne E. Association between changes in lumbar Modic changes and low back symptoms over a two-year period. BMC Musculoskelet Disord. 2015 Apr 22;16:98. doi: 10.1186/s12891-015-0540-3. — View Citation

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Kjaer P, Bendix T, Sorensen JS, Korsholm L, Leboeuf-Yde C. Are MRI-defined fat infiltrations in the multifidus muscles associated with low back pain? BMC Med. 2007 Jan 25;5:2. — View Citation

Kovacs FM, Urrútia G, Alarcón JD. Surgery versus conservative treatment for symptomatic lumbar spinal stenosis: a systematic review of randomized controlled trials. Spine (Phila Pa 1976). 2011 Sep 15;36(20):E1335-51. doi: 10.1097/BRS.0b013e31820c97b1. Review. — View Citation

Marcolino JA, Mathias LA, Piccinini Filho L, Guaratini AA, Suzuki FM, Alli LA. Hospital Anxiety and Depression Scale: a study on the validation of the criteria and reliability on preoperative patients. Rev Bras Anestesiol. 2007 Feb;57(1):52-62. English, Portuguese. — View Citation

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Pilz B, Vasconcelos RA, Marcondes FB, Lodovichi SS, Mello W, Grossi DB. The Brazilian version of STarT Back Screening Tool - translation, cross-cultural adaptation and reliability. Braz J Phys Ther. 2014 Sep-Oct;18(5):453-61. Epub 2014 Aug 29. English, Portuguese. — View Citation

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* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sociodemographic characteristics	Age (years), sex (male or female), body mass index (BMI), formal education (years of study), type of occupation (carrying weight or not).	Baseline
Primary	Change in Pain Intensity	Pain intensity will be measured using VAS 0-10 (0 being no pain and 10 maximum pain)	Baseline, 3, 6, 12 and 24 months after surgery
Secondary	Radiological evaluation	Magnetic resonance imaging (MRI) reading parameters of Paravertebral and Psoas major fat tissue infiltration follow the standardized institutional protocol for spine evaluation.	Baseline and 6 month after surgery
Secondary	Change in Kinesiophobia	Assessment of fear avoidance beliefs related to physical activity and work will be evaluated by the questionnaire Fear avoidance Beliefs Questionnaire (FABQ)	Baseline, 3, 6, 12 and 24 months after surgery
Secondary	Change in Psychosocial Risk Prognosis	Psychosocial risk prognosis will be measured by the brazilian version of the STarT Back screening tool.	Baseline, 3, 6, 12 and 24 months after surgery
Secondary	Change in Global Impression of Recovery	Global impression of recovery will be measured by the Global Perceived Effect of Change(GPE)	Baseline, 3, 6, 12 and 24 months after surgery
Secondary	Change in Mood Disorders in The setting of Medical Practice	Anxiety and depression aspects will be measured by the Hospital Anxiety and Depression Scale (HADS)	Baseline, 3, 6, 12 and 24 months after surgery
Secondary	Change in Disability	Disability will be measured by the Oswestry Disability Index, Brazilian version 2.0.	Baseline, 3, 6, 12 and 24 months after surgery
Secondary	Change in Quality life	EuroQoL will be combined with a Visual Analogue Scale(VAS) to carry out the cost-effectiveness analysis of the second opinion program.	Baseline, 3, 6, 12 and 24 months after surgery